FDA.reportPublic FDA data

Repose Companion Cover

Primary DI
05056279301008
Brand
Repose Companion Cover
Company
Frontier Therapeutics Inc
Model
6990002
Device description
Repose Companion Cover
Published
2021-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
05056279301008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056279301008050562793010085056279301008

GMDN Terms#

Term, Definition table
TermDefinition
Waterproof bed mattress cover, reusableA device made of soft, waterproof material that is shaped to fit over a bed mattress to create a physical barrier to protect the mattress, prevent cross-contamination, and prevent exposure to soiling, typically bedwetting or spills of other liquids. It can be laundered for cleaning. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800)303-9544contactus@frontier-therapeutics.com

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