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COVID-19 Specifications and Vendor Questionnaire – 3.29.2020 v2Vendor Name:Vendor Website:Contact Information:Name:E-mail:Phone:Date of Response:Please identify those products you can provide to the State:Product TypeCheck (X) if YESVentilatorsGlovesGownsDisinfecting WipesMasksGogglesGlassesFace ShieldsTesting SwabsTesting KitsHand SanitizersHospital BedsCadaver Body Bags(List Here) Additional Products…………In addition to checking the boxes above, please list any additional products you can offer to the State and complete the requested information for all products you can provide. GENERAL QUESTIONSAre you currently registered in SIGMA as a State Vendor?If yes, please provide your vendor number.Are you a Michigan based company?Are you a United States based Company? Do you have warehousing in Michigan?Do you have warehousing in the United States?Procurement / Purchasing terms: Is Pre-pay required?Do you accept credit card? If yes, what is the maximum transaction size?If shipping from overseas, do you intend to use air freight?1381125-16954500Ventilators RequirementsMust be FDA clearedVentilator specific standards for COVID-19 Healthcare Coalitions have the following ventilators in their regions and match the anticipated SNS stock. These can be used for specification comparison: List of Ventilators:Medtronic 840? g5? Evita? 731? Evo R860 LTV SpecsPlease list here or attach your product specs and provide a descriptionIs your product a medical device? Is your product designed to serve as PPE?Is this FDA approved?Is this OSHA certified?Do you currently have the product on hand in the US currently?Is there a minimum/maximum order quantity?Is the brand listed above? Please specify.Ordering – Please discuss the ordering process and describe when you can deliver the product to our specified locationAvailability – What is your lead time for shipment and delivery?Pricing – Provide pricing estimates based on large qty tiers and indicate if shipping is included in price1114425-323215GlovesRequirementsNitrile Powder Free Gloves Only – No latex, vinyl, plasticMust be FDA approvedGloves are regulated by the FDA as Class I reserved medical devices that require a 510(k) premarket notification (safe, effective and substantially equivalent to substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). Gloves SpecsPlease list here or attach your product specs and provide a descriptionIs your product a medical device? Is your product designed to serve as PPE?Is this FDA approved?Is this OSHA certified?Do you currently have the product on hand in the US currently?Is there a minimum/maximum order quantity?What is the thickness?What sizes are available?Are they medical, industrial, or food grade?Are they sterile?Palletizing - We need pallets of gloves to be clearly marked with the type of gloves. Can you do this? If a mixture of gloves is ordered can you palletize a mixture of sizes of the same type to assist in distributionOrdering – Please discuss the ordering process and describe when you can deliver the product to our specified locationAvailability – What is your lead time for shipment and delivery?Pricing – Provide pricing estimates based on large qty tiers and indicate if shipping is included in price.1114425-338455GownsRequirementsMust use gowns that meet CDC recommendations and/or ANSI standards for fluid resistance and bacterial filtration efficiency. see “When No Gowns Are Available” sectionCDC has issued guidance for the manufacturing of clothing (cloth) for gowns for in COVID-19 crisis use Current Healthcare Protective Clothing Standards and Specifications Society for Testing and Materials (ASTM) F2407 is an umbrella document which describes testing for surgical isolation gowns:? tear resistance, seam strength, lint generation, evaporative resistance, and water vapor transmission.?FDA Class II medical device is classification is used for surgical isolation gowns, that requires a 510(k) premarket notification. All areas of the surgical isolation gown?except bindings, cuffs, and hems are considered critical zones of protection and must meet the highest liquid barrier protection level for which the gown is rated.? All seams must have the same liquid barrier protection as the rest of the gown.?See below:The State will consider any of the levels specified below:Level 1 – Basic care, standard hospital medical unitLevel 2 – Blood draw from a vein, suturing, intensive care unit, pathology labLevel 3 – Arterial blood draw, inserting and IV, emergency room, traumaLevel 4 – Pathogen resistance, infectious diseases (non-airborne), large amounts of fluid exposure over long periods of time.Gown SpecsPlease list here or attach your product specs and provide a descriptionIs your product a medical device? Is your product designed to serve as PPE?Is this FDA approved?Is this OSHA certified?Do you currently have the product on hand in the US currently?Is there a minimum/maximum order quantity?Does your material meet the American Society for Testing and Materials (ASTM) F2407?Does your product meet the ANSI/AAMI PB70 standard for liquid barrier performance? If yes, at which level?Do all areas of the surgical isolation gown except bindings, cuffs, and hems are considered critical zones of protection and meet the highest liquid barrier protection level for which the gown is rated?Do all seams have the have the same liquid barrier protection as the rest of the gown?What sizes are available?Please provide or attach images.Palletizing - We need pallets of gloves to be clearly marked with the type of gloves. Can you do this? If a mixture of gowns is ordered can you palletize a mixture of sizes of the same type to assist in distributionOrdering – Please discuss the ordering process and describe when you can deliver the product to our specified locationAvailability – What is your lead time for shipment and delivery?Pricing – Provide pricing estimates based on large qty tiers and indicate if shipping is included in price2371725-170815Disinfecting WipesRequirementsMust at a minimum be effective on HIV, Herpes, SARSDisinfecting Wipe SpecsPlease list here or attach your product specs and provide a descriptionIs this FDA approved?Is this OSHA certified?Do you currently have the product on hand in the US currently?Is there a minimum/maximum order quantity?Is this effective on HIV, Herpes and SARS?Ordering – Please discuss the ordering process and describe when you can deliver the product to our specified locationAvailability – What is your lead time for shipment and delivery?Pricing – Provide pricing estimates based on large qty tiers and indicate if shipping is included in price1123950-170815MasksRequirementsVendor to provide specs below:Masks SpecsPlease list here or attach your product specs and provide a descriptionIs your product a medical device? Is your product designed to serve as PPE?Is this FDA approved?Is this OSHA certified?Do you currently have the product on hand in the US currently?Is there a minimum/maximum order quantity?What type of mask (NIOSH rating) is this?Ordering – Please discuss the ordering process and describe when you can deliver the product to our specified locationAvailability – What is your lead time for shipment and delivery?Pricing – Provide pricing estimates based on large qty tiers and indicate if shipping is included in price1241425-9080500GogglesRequirementsMust comply with Any new eye and face protective devices must comply with American National Standards Institute (ANSI) Z87.1-1989 and OSHA Personal Protective Equipment guidelinesOSHA definition: Goggles are tight-fitting eye protection that completely cover the eyes, eye sockets and the facial area immediately surrounding the eyes and provide protection from impact, dust and splashes. Some goggles will fit over corrective lenses.Must be anti-fog Goggles SpecsPlease list here or attach your product specs and provide a descriptionIs your product a medical device? Is your product designed to serve as PPE?Is this FDA approved?Is this FDA certified?Is this OSHA certified?Does your product comply with with American National Standards Institute (ANSI) Z87.1-1989 and OSHA Personal Protective Equipment guidelinesDo you currently have the product on hand in the US currently?Is there a minimum/maximum order quantity?Are these completely sealed around the eye?Are these anti-fog?Are these vented?Ordering – Please discuss the ordering process and describe when you can deliver the product to our specified locationAvailability – What is your lead time for shipment and delivery?Pricing – Provide pricing estimates based on large qty tiers and indicate if shipping is included in price1161415-34226500Glasses RequirementsMust be anti-fogSolid side shieldsGlasses SpecsPlease list here or attach your product specs and provide a descriptionIs your product a medical device? Is your product designed to serve as PPE?Is this FDA approved?Is this FDA certified?Is this OSHA certified?Do you currently have the product on hand in the US currently?Is there a minimum/maximum order quantity?Do they have solid side shields?Are these anti-fog?Ordering – Please discuss the ordering process and describe when you can deliver the product to our specified locationAvailability – What is your lead time for shipment and delivery?Pricing – Provide pricing estimates based on large qty tiers and indicate if shipping is included in price1857375-104775Face Shields RequirementsAny new eye and face protective devices must comply with American National Standards Institute (ANSI) Z87.1-1989 and OSHA Personal Protective Equipment guidelinesOSHA definition: Face shields are transparent sheets of plastic extend from the eyebrows to below the chin and across the entire width of the employee’s head. Some are polarized for glare protection. Face shields protect against nuisance dusts and potential splashes or sprays of hazardous liquids but will not provide adequate protection against impact hazards. Face shields used in combination with goggles or safety spectacles will provide additional protection against impact hazards.Must be anti-fogFace Shields SpecsPlease list here or attach your product specs and provide a descriptionIs your product a medical device? Is your product designed to serve as PPE?Is this FDA approved?Is this FDA certified?Is this OSHA certified?Does your product comply with with American National Standards Institute (ANSI) Z87.1-1989 and OSHA Personal Protective Equipment guidelinesDo you currently have the product on hand in the US currently?Is there a minimum/maximum order quantity?Do you have any product testing data or information on regarding anti-fogging?Ordering – Please discuss the ordering process and describe when you can deliver the product to our specified locationAvailability – What is your lead time for shipment and delivery?Pricing – Provide pricing estimates based on large qty tiers and indicate if shipping is included in priceTesting Swabs Requirements3/20/2020 List of acceptable NP swabs & Viral Transport Media per the FDA Acceptable Swabs for COVID-19 Testing:See below for a list of individually wrapped swabs. All swabs are flocked unless noted:UTM? 305C? (Hardy Code 3C036NHL)? Nasopharyngeal Swab Swab ?Puritan Nasopharyngeal swabs: 25-3317-H, 25-1406 1PF 50f, 25-800 1PD 50**, 25-3320-U,Copan Nasopharyngeal swabs: 503CS01, 518CS01, and 501CS01, 502CS01BD Nasopharyngeal swabs: 220252 and 220251DHI/Quidel Nasopharyngeal swabs: 503CS01.DHIFisher Healthcare Nasopharyngeal swabs: 23600952, 23600956 and 23600950 Puritan Oropharyngeal swabs: 25-1506 1PF SOLIDf, 25-1506 1PF 100 f, 25-3206-H, 25-3206-U, 25-3706-H, 25-806 1PD** and 25-806 1PD BT**Copan Oropharyngeal swabs: 502CS01, 519CS01, 164KS01**, 167KS01**, 170KS01** and 175KS01**BD Oropharyngeal swabs: 220250Fisher Healthcare Oropharyngeal swabs: 23600950, 23600957, 1490641**, 1490640** and 1490650**Additional sterile flocked swabs from Puritan that may be used: 25-3316-U, 25-3316-H, 25-3317-U, 25-3318-U, 25-3318-H, 25-3320-U, 25-3320-H and 25-3319-HfFoam swab**Polyester swabAcceptable Universal Transport Media for Viruses & Molecular Transport MediaExamples of universal transport media for viruses and molecular transport media are listed here. All of the products listed below include a nasopharyngeal (NP) flocked swab unless noted otherwise.Copan: 305C, 307C, 360C and 519CS01*Puritan: UT-367, UT-317, UT-302*, UT-366** and UT-300***Hardy/Healthlink: 330CHLBD: 220220, 220252 220251 and 220250*DHI/Quidel: 330C.DHI and 503CS01.DHIFisher Healthcare: 23001718, 23600952, 23600956, 23600950 and 23600957*PrimeStore MTM: LH-1-02 and LH-1-03****flocked oropharyngeal swab**Polyester swab***no swabLiquid Amies media may be used for viral transport when universal transport media is not available. All of the products listed below include a nasopharyngeal (NP) flocked swab unless noted otherwise.Copan: 481C, 482C 480C* and 480CFA*Puritan: LA-117, LA-116-H and LA-100***BD: 220245, 220532 and 220245*ThermoFisher: R723481, R723482 and R723480*Hardy/Healthlink: 481C, 482C 480C* and 480CFA*VWR: 89136-656, 89136-658, 89136-654* and 76181-494*Fisher Healthcare: 23600901, 23600902, 23600900* and 23600905**flocked oropharyngeal swab***no swabTesting Swab SpecsPlease list here or attach your product specs and provide a descriptionIs this FDA approved?Is this OSHA certified?Do you currently have the product on hand in the US currently?Is there a minimum/maximum order quantity?Is this test on the list ofof acceptable NP swabs & Viral Transport Media per the FDA Acceptable Swabs for COVID-19 Testing.Ordering – Please discuss the ordering process and describe when you can deliver the product to our specified locationAvailability – What is your lead time for shipment and delivery?Pricing – Provide pricing estimates based on large qty tiers and indicate if shipping is included in price16002001016000Testing KitsRequirementsFDA ApprovedTesting Kits SpecsPlease list here or attach your product specs and provide a descriptionIs this FDA approved?Is this OSHA certified?Do you currently have the product on hand in the US currently?Is there a minimum/maximum order quantity?Is this approved by the CDC?Ordering – Please discuss the ordering process and describe when you can deliver the product to our specified locationAvailability – What is your lead time for shipment and delivery?Pricing – Provide pricing estimates based on large qty tiers and indicate if shipping is included in price1536700-8191500Hand SanitizersRequirementsManufactured following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20; or Isopropyl Alcohol (75%, v/v) in an aqueous solutionGlycerol (1.45% v/v)Hydrogen peroxide (0.125% v/v)Sterile distilled water or boiled cold waterHand sanitizer specific standard for COVID-19 Sanitizer SpecsPlease list here or attach your product specs and provide a descriptionIs this FDA approved?Is this OSHA certified?Do you currently have the product on hand in the US currently?Is there a minimum/maximum order quantity?Is this effective on HIV, Herpes and SARS?Ordering – Please discuss the ordering process and describe when you can deliver the product to our specified locationAvailability – What is your lead time for shipment and delivery?Pricing – Provide pricing estimates based on large qty tiers and indicate if shipping is included in price1339850698500Hospital Beds RequirementsHead of the bed needs to be elevated to 45 degreesThe entire bed needs to be able to elevated to provide careThe bed needs to be mobile, thus wheels with locks are necessary Mechanical and motorized functions are both desirable due to unknown locations of alternate sites of care Mattresses need to be non-permeable surface Consider ? side railsHospital Bed SpecsPlease list here or attach your product specs and provide a descriptionIs this FDA approved?Is this OSHA certified?Do you currently have the product on hand in the US currently?Is there a minimum/maximum order quantity?Can the head of the bed be elevated to 45 degrees?Can the entire bed elevated to provide care?Is the bed mobile? If yes, does it have wheel locks? Is the bed mechanical and motorized? These functions are both desirable due to unknown locations of alternate sites of care.Does this include a mattress? If yes, is the surface of the mattress non-permeableOrdering – Please discuss the ordering process and describe when you can deliver the product to our specified locationAvailability – What is your lead time for shipment and delivery?Pricing – Provide pricing estimates based on large qty tiers and indicate if shipping is included in priceBody Bags Specs from previously acquired products: Standard Body Bag:7mm High Strength VinylEnvelope Style Zipper for easy accessRust resistant #5 Nylon ZipperLength 90” x Width 36” x GIrth 84”Heavy Duty Body Bag:Reinforced by 1 ?" nylon webbingHeat sealed seams for superior liquid and gas leakage resistanceDual zipper system/6 handles for easy liftingBlack 12mm Poly Chloride VinylLength 84” x Width 40” x GIrth 84”Pediatric Body Bag:7mm High Strength VinylEnvelope Style Zipper for easy accessRust resistant #5 Nylon Zipper33” x 49”Is your product a medical device? (If no skip to question #5)Is your product designed to serve as PPE?Is this FDA approved?Is this OSHA certified?Do you currently have the product on hand in the US currently?Is there a minimum/maximum order quantity?Is pre-pay required?Ordering – Please discuss the ordering process and describe when you can deliver the product to our specified locationAvailability – What is your lead time for shipment and delivery?Pricing – Provide pricing estimates based on large qty tiers and indicate if shipping is included in priceAdditional Products – complete table for each itemRepeat the table as needed for additional products you can source the State related to COVID-19:LIST PRODUCT TYPEPlease list here or attach your product specsIs your product a medical device? (If no skip to question #5)Is your product designed to serve as PPE?Is this FDA approved?Is this OSHA certified?Do you currently have the product on hand in the US currently?Is there a minimum/maximum order quantity?Is pre-pay required?Ordering – Please discuss the ordering process and describe when you can deliver the product to our specified locationAvailability – What is your lead time for shipment and delivery?Pricing – Provide pricing estimates based on large qty tiers and indicate if shipping is included in price ................
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