FDA.report

Drive

Primary DI
00822383257907
Brand
Drive
Company
Drive Devilbiss Healthcare
Model
15777
Device description
Pressure PreventionLTC and Hospice Product Description: GRAVITY 7 MATTRESS W/ELEV PERIM,80",1/EA
Published
2019-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IKYMATTRESS, FLOTATION THERAPY, NON-POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
IKYMattress, Flotation Therapy, Non-PoweredGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00822383257907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383257907008223832579078223832579070822383257907

GMDN Terms

TermDefinition
Gel-filled bed mattressA large, durable, fabric case filled with various densities of foam that support a gel structure, designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and intended to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
867673159
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00822383012162Silver Sport 16" Full ArmSSP16RBDFAV2026-02-03
00822383012179Silver Sport 18" Det DeskSSP18RBDDAV2026-02-03
00822383012186Silver Sport 18" Full ArmSSP18RBDFAV2026-02-03
00822383012193Silver Sport 20" Det DeskSSP20RBDDAV2026-02-03
00822383012209Silver Sport 20" Full ArmSSP20RBDFAV2026-02-03
00822383034683Silver Sport HD 22"SSP22RBDDAV2026-02-03
00822383034690Silver Sport 24" HDSSP24RBDDAV2026-02-03
00822383030135AeroFly Wheelchair, 18”, Black, SFAF18FDABK-SF2025-11-18
00822383030142AeroFly Wheelchair, 18”, Gray, SFAF18FDAGY-SF2025-11-18
00822383033204AeroFly Wheelchair 20:, Black, SFAF20FDABK-SF2025-11-11
00822383033211AeroFly Wheelchair 20:, Gray, SFAF20FDAGY-SF2025-11-11
00822383033228AeroFly Transport Chair, 18", BlackAFT18BK-SF2025-11-11
00822383033235AeroFly transport Chair, 18", GrayAFT18GY-SF2025-11-11
00822383030333DriveCFPC17FS2025-09-03
00822383000190Drive35BWBE-FM-SC0535BWBE-FM-SC052025-09-02
00822383000206Drive35MCBE-B-SC0535MCBE-B-SC052025-09-02
00822383000213Drive35MCBE-A-SC0535MCBE-A-SC052025-09-02
00822383000220Drive35MCBE-FM-SC0535MCBE-FM-SC052025-09-02
00822383000237Drive42BWBE-B-SC0542BWBE-B-SC052025-09-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00887761010901Stretcher SurfaceHILL-ROM, INC.IKY2026-02-19
00887761010918Stretcher SurfaceHILL-ROM, INC.IKY2026-02-19
00887761010925Stretcher SurfaceHILL-ROM, INC.IKY2026-02-19
05059441461654TherarestArjohuntleigh ABIKY2026-02-10
00810178885084ViveVIVE HEALTH LLCIKY2026-02-02
00810178885091ViveVIVE HEALTH LLCIKY2026-02-02
H93353893Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-12-01
H93313584Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-09-04
H93335834Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-08-04
H93338296Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-08-04
00841447115151Invacare Solace MattressINVACARE CORPORATIONIKY2025-06-30
00841447115137Invacare Solace MattressINVACARE CORPORATIONIKY2025-06-23
H933MX8435NZ29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-04-22
H933PR8036RP29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-04-22
H933PR8436RP29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-04-22
H933PR8436FP29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-03-12
H933PR8036FP29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-02-07
00840828193887BED MAT-7X36X88-CEN CORE-FOAM-PCCURBELL MEDICAL PRODUCTS, INC.IKY2025-01-08
00840828193894BED MAT-7X36X88-CENPROAF-PCCURBELL MEDICAL PRODUCTS, INC.IKY2025-01-08
H933UMX884829Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2024-12-03
00092237616246MERIDIAN MEDICALCOMPASS HEALTH BRANDS CORP.IKY2024-08-16
H93334371Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2024-08-13
00887761995116PROGRESSA+ ESSENTIAL SURFACEHill-Rom de México, S. de R.L. de C.V.IKY2024-07-12
00815067072941PROBASICSCOMPASS HEALTH BRANDS CORP.IKY2024-06-25
00841447114826Invacare EssentialsINVACARE CORPORATIONIKY2024-06-03
00841447114833Invacare EssentialsINVACARE CORPORATIONIKY2024-06-03
00841447114840Invacare EssentialsINVACARE CORPORATIONIKY2024-06-03
00841447114857Invacare EssentialsINVACARE CORPORATIONIKY2024-06-03
H933A803529B0Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2024-06-03
H933A804229B0Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2024-06-03