FDA.reportPublic FDA data

Repose Contur Cover

Primary DI
05056279300940
Brand
Repose Contur Cover
Company
Frontier Therapeutics Inc
Model
6310000
Device description
Repose Contur Cover
Published
2021-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FMWCover, Mattress (Medical Purposes)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMWCover, Mattress (Medical Purposes)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056279300940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056279300940050562793009405056279300940

GMDN Terms#

Term, Definition table
TermDefinition
Air-filled chair cushionA static-air-inflated pad designed to be placed on the seat of a chair to distribute an occupant's body weight over the surface of the buttocks, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized patients especially in cases of decubitus ulcers, patients with disabilities, or patients with low body fat. It may be used in a wheelchair. 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
05056279303682Repose Mattress Cushion and Pump (10 Singles)71211012021-03-31
05056279303743Repose Cushion and Pump (10 Singles)72011002021-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840828196291BED COVER-4X36X88-CEN PRO PLUS MAT TOP-PCURBELL MEDICAL PRODUCTS, INC.FMW2026-04-08
00850045714581Soteria Mattress BarrierTrinity Guardion, Inc.FMW2026-03-10
00840828195898BED COVER-4X36X84-PROGRESSA PULM TOP-PCCURBELL MEDICAL PRODUCTS, INC.FMW2026-01-20
00850056748292FORWARD APLS Litter GuardINTEGRATED MEDCRAFT LLCFMW2026-01-15
07640178061446CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061736CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061828CT Table CoverPearl Technology AGFMW2025-12-17
07640178061835CT Table CoverPearl Technology AGFMW2025-12-17
07640178061842CT Table CoverPearl Technology AGFMW2025-12-17
07640178061927CT Table CoverPearl Technology AGFMW2025-12-17
07640178061934CT Table CoverPearl Technology AGFMW2025-12-17
07640178061941CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061958CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061965CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061972CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061989CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061996CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062009CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062016CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062023CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062030CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062047CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062054CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062061CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062184CT Table CoverPearl Technology AGFMW2025-12-17
07640178062191CT Table CoverPearl Technology AGFMW2025-12-17
07640178062207CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062214CT Table CoverPearl Technology AGFMW2025-12-17
00850056748315FORWARD APLS Surgery SoakerINTEGRATED MEDCRAFT LLCFMW2025-11-06
00850045714529Soteria Neonatal Mattress BarrierTrinity Guardion, Inc.FMW2025-10-20