FDA.reportPublic FDA data

"Universal Mattress Cover with Defined Perimeter, 80"" x 36"" x 6"""

Primary DI
00616784048512
Brand
"Universal Mattress Cover with Defined Perimeter, 80"" x 36"" x 6"""
Company
Dynarex Corporation
Model
10485
Published
2022-04-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FMWCover, Mattress (Medical Purposes)
FNMMattress, Air Flotation, Alternating Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMWCover, Mattress (Medical Purposes)General Hospital1
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784048512PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784048512006167840485126167840485120616784048512

GMDN Terms#

Term, Definition table
TermDefinition
Bed mattress/cover setA collection of devices designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie and rest/sleep, and which may help to promote therapeutic postures. It typically consists of a bed mattress, mattress overlay/cover and wedge-shaped cushion which are typically made of knitted polyester, polyurethane foam, buckwheat husk or combinations of materials. This is a reusable device after appropriate cleaning.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117305274Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1500301012021-04-22
00840117305298Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1000301032021-04-22
00840117305656Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1500301002021-04-22
00840117305847Resp-O2 Heat Moisture Exchanger + Filter (HMEF) 1500301022021-04-22
00840117307728Ever-Soft Positioning Wedge130012021-04-22
00840117307742Ever-Soft Positioning Wedge130022021-04-22
00840117307766Ever-Soft Positioning Wedge130032021-04-22
00840117321045Bari+Max Bariatric Gel Foam Wheelchair Cushion 24"x18"x3"130542021-04-22
00840117321052Bari+Max Bariatric Gel Foam Wheelchair Cushion 26"x20" "x3"130552021-04-22
00840117321090Bari+Max Bariatric Gel/Foam Cushion 22"x18"x3"130502021-04-22
00840117321106Bari+Max Bariatric Gel/Foam Cushion 24"x18"x3"130512021-04-22
00616784304113Dmecare Solutions Solid Seat Insert13041-162021-09-01
00616784304212DMECare Solutions Solid Seat Insert13041-182021-09-01
00616784304311DMECare Solutions Solid Seat Insert13041-202021-09-01
00616784304410DMECare Solutions Solid Seat Insert13041-222021-09-01
00616784304519DMECare Solutions Solid Seat Insert13041-242021-09-01
00840117321021Bariatric Reclining Wheelchair 24" with Elevating Leg Rest15015-24DELR2024-05-08
00840117321168DynaRide Pediatric Wheelchair with Footrest 12"15009-12DFR2024-05-09
00840117321175DynaRide Pediatric Wheelchair with Footrest 14"15009-14DFR2024-05-09
00840117322684Bariatric Reclining Wheelchair 26" with Elevating Leg Rest15015-26DELR2024-05-08

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Primary DI, Brand, Company table
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04719876190215TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876190482TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876190499TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876191991TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876192004TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876192202TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876192219TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
G771PDA91003680Pro-Daptive SensorCell Flotation SurfaceLEVISENSE MEDICAL, INC.FNM2026-06-09
00817012031874K-2oem ALT-AIRE+KAP MEDICALFNM2026-05-29
00817012031904K-4 D3XKAP MEDICALFNM2026-05-29
00817012031911K-4 D3XKAP MEDICALFNM2026-05-29
04719893356434WellellWellell Inc.FNM2026-04-20
H93338036Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338042Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
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H93338442Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H9336200Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
04719893356922WellellWellell Inc.FNM2026-03-20
H933PR13051Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2025-12-01
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H93364565Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2024-02-14
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20686864054928AMD-RITMEDAMD Medicom IncFMW2023-07-11