FDA.reportPublic FDA data

Repose Mattress Cushion and Pump (10 Singles)

Primary DI
05056279303682
Brand
Repose Mattress Cushion and Pump (10 Singles)
Company
Frontier Therapeutics Inc
Model
7121101
Device description
Repose Mattress Cushion and Pump (10 Singles)
Published
2021-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
IKYMattress, Flotation Therapy, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKYMattress, Flotation Therapy, Non-PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056279303682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056279303682050562793036825056279303682

GMDN Terms#

Term, Definition table
TermDefinition
Air-filled bed mattress overlayA static-air-inflated pad or thin mattress, usually full-body length, which is placed on top of a bed mattress to distribute an occupant's body weight over a large surface area, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
111598708
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00505627930841Repose Flex Large x10 &Pump x167501142026-06-05
05056279308434Repose Flex Large x1 & Pump x167500042026-06-05
05056279308458Repose Flex Large x10 &Pump x1077500042026-06-05
05056279301428Repose Mattress and Pump (Bulk Pack 10)6111002021-03-31
05056279301602Repose Cushion (Bulk Pack 10)62001012021-03-31
05056279302029Repose Footprotector (Pair) (Bulk Pack 10)65002002021-03-31
05056279302036Repose Long Footprotectors (Pair) (Bulk Pack 10)65002012021-03-31
05056279302258Repose Footprotector PLUS (Pair) (Bulk Pack 10)65111102021-03-31
05056279302296Repose Small Footprotector (Bulk Pack 10) with Pump65201002021-03-31
05056279302340Repose Extra Small Footprotector (Bulk Pack 10) with Pump65301002021-03-31
05056279302395Repose Small Footprotector Plus (Bulk Pack 10) with Pump65401002021-03-31
05056279302425Repose Small Footprotectors Plus (Single) and Pump65411032021-03-31
05056279302432Repose Extra Small Footprotector Plus (Bulk Pack 10) with Pump65501002021-03-31
05056279303279Repose Sole Protector x 1 with Small Pump69300012021-03-31
05056279303521Repose Trolley Mattress and Pump (10 Singles)76011002021-03-31
05056279303613Repose Mattress Overlay and Pump (10 Singles)70111002021-03-31
05056279303620Repose 1 Long Footprotector and Pump (10 Singles)70210002021-03-31
05056279303637Repose Long Footprotectors (pair) and Pump - 10 Singles70211002021-03-31
05056279303743Repose Cushion and Pump (10 Singles)72011002021-03-31
05056279303774Repose Babytherm and Pump (10 Singles)74011002021-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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
08592654851067Ergozone 3000L I N E T spol. s r.o.IKY2025-11-03
08592654851074Ergozone 3000L I N E T spol. s r.o.IKY2025-11-03
08592654851081Ergozone 3000L I N E T spol. s r.o.IKY2025-11-03
00841447115175Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
00841447115182Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
00841447115199Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
00841447115205Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
05056147701497Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701503Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701510Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701527Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701534Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701541Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701558Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701565Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701572Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
05056147701589Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
05056147701596Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
05056147701602Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
H93331629Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-09-04
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