Repose Mattress Overlay 6011100

GUDID 05056279301152

Repose Mattress Overlay is designed for use on a standard single mattress, where it is proven to provide effective pressure redistribution. Suitable for use in both acute and community settings, Repose Mattress Overlay comes packaged inside a unique and easy to use pump, which enables the mattress overlay to be inflated ready for use within seconds, and the smart valve ensures that the product is inflated to the optimal pressure.

Frontier Therapeutics Inc

Air-filled bed mattress overlay Air-filled bed mattress overlay Air-filled bed mattress overlay Air-filled bed mattress overlay Air-filled bed mattress overlay Air-filled bed mattress overlay Air-filled bed mattress overlay Air-filled bed mattress overlay Air-filled bed mattress overlay Air-filled bed mattress overlay Air-filled bed mattress overlay Air-filled bed mattress overlay Air-filled bed mattress overlay Air-filled bed mattress overlay Air-filled bed mattress overlay Air-filled bed mattress overlay
Primary Device ID05056279301152
NIH Device Record Keycc07a1d9-27a1-44d9-8179-295c2d500b06
Commercial Distribution StatusIn Commercial Distribution
Brand NameRepose Mattress Overlay
Version Model Number6011100
Catalog Number6011100
Company DUNS111598708
Company NameFrontier Therapeutics Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105056279301152 [Primary]

FDA Product Code

IKYMattress, Flotation Therapy, Non-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-02
Device Publish Date2021-03-25

Devices Manufactured by Frontier Therapeutics Inc

05056279301428 - Repose Mattress and Pump (Bulk Pack 10)2021-04-08 Repose Mattress and Pump (Bulk Pack 10)
05056279301602 - Repose Cushion (Bulk Pack 10)2021-04-08 Repose Cushion (Bulk Pack 10)
05056279302029 - Repose Footprotector (Pair) (Bulk Pack 10)2021-04-08 Repose Footprotector (Pair) (Bulk Pack 10)
05056279302036 - Repose Long Footprotectors (Pair) (Bulk Pack 10)2021-04-08 Repose Long Footprotectors (Pair) (Bulk Pack 10)
05056279302258 - Repose Footprotector PLUS (Pair) (Bulk Pack 10)2021-04-08 Repose Footprotector PLUS (Pair) (Bulk Pack 10)
05056279302296 - Repose Small Footprotector (Bulk Pack 10) with Pump2021-04-08 Repose Small Footprotector (Bulk Pack 10) with Pump
05056279302340 - Repose Extra Small Footprotector (Bulk Pack 10) with Pump2021-04-08 Repose Extra Small Footprotector (Bulk Pack 10) with Pump
05056279302395 - Repose Small Footprotector Plus (Bulk Pack 10) with Pump2021-04-08 Repose Small Footprotector Plus (Bulk Pack 10) with Pump

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