FDA.reportPublic FDA data

Air Float Static Air Mattress Overlay

Primary DI
00810006680195
Brand
Air Float Static Air Mattress Overlay
Company
PRIMO INC
Model
AF76343
Catalog number
AF76343
Device description
"Air Float Static Air Mattress Overlay ( 76""x34""x3"")"
Published
2019-02-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FMPProtector, Skin Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810006680195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810006680195008100066801958100066801950810006680195

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair cushionA padded device designed to provide support, comfort, and assistance to the occupant of a wheelchair. It may be used to improve posture, provide back and/or side support, compensate for seat height, relieve stress points, and provide pressure alleviation for the buttocks, lumbar region, and the legs, and/or to provide an antislip mechanism. The device is typically situated behind the lower lumbar region of the back or under the buttocks and/or legs while the occupant is seated. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
958758146
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810006680072Glide & Guide Turn Sheet GGS3660GGS36602019-02-27
00810006680089Glide & Guide Turn Sheet GGS3660TSGGS3660TS2019-02-27
00810006680096Glide & Guide Turn Sheet GGS5660GGS56602019-02-27
00810006680355Glide & Guide Turn Sheet Select GGS3660FGGS3660F2019-02-27
00810006680362Glide & Guide Turn Sheet Select GGS3660SSFGGS3660SSF2019-02-27
00810006680379Glide & Guide Turn Sheet GGS3660SSGGS3660SS2019-02-27
00810006680386Glide & Guide Turn Sheet Select GGS3660TSFGGS3660TSF2019-02-27
00810006680393Glide & Guide Turn Sheet GGS4460GGS44602019-02-27
00810006680409Glide & Guide Turn Sheet GGS4460SSGGS4460SS2019-02-27
00810006680416Glide & Guide Turn Sheet GGS4460TSGGS4460TS2019-02-27
00810006680423Glide & Guide Turn Sheet Select GGS5660FGGS5660F2019-02-27
00810006680430Glide & Guide Turn Sheet GGS5660SSGGS5660SS2019-02-27
00810006680447Glide & Guide Turn Sheet Select GGS5660SSFGGS5660SSF2019-02-27
00810006680454Glide & Guide Turn Sheet GGS5660TSGGS5660TS2019-02-27
00810006680461Glide & Guide Turn Sheet Select GGS5660TSFGGS5660TSF2019-02-27
00810006681574Glide & Guide Turn Sheet GGS3660PSGGS3660PS2019-02-27
00810006681598Glide & Guide Turn Sheet GGS5660PSGGS5660PS2019-02-27
00810006682366Synthetic Sheepskin Bed OverlaySS3024SS30242019-02-27
00810006682373Synthetic Sheepskin Bed OverlaySS3040SS30402019-02-27
00810006682380Synthetic Sheepskin Bed OverlaySS3060SS30602019-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850018561037Gel-E DonutINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561044Gel-E DonutINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561051Gel-E DonutINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561068SquishonINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561075SquishonINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561082SquishonINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00089904011503Action®ACTION PRODUCTS, INC.FMP2026-09-30
07333350181475Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350455873Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350647292Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350743918Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350775360Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350462161Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
07333350529079Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
07333350768249Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
00860015694713Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694720Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694737Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694744Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694751Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694768Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00089904011459Action®ACTION PRODUCTS, INC.FMP2026-07-23
00089904011435Action®ACTION PRODUCTS, INC.FMP2026-07-21
00089904011442Action®ACTION PRODUCTS, INC.FMP2026-07-21
00609271999336Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999343Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999374Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999381Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999473Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999480Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20