AirFloat Static Air Seat Cushion AF1717

GUDID 10810006683520

AirFloat Static Air Seat Cushion (17"x17")

PRIMO INC

Freestanding patient positioner, single-use
Primary Device ID10810006683520
NIH Device Record Key49b1590a-a0f9-4219-a2e6-d7452cbe299d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAirFloat Static Air Seat Cushion
Version Model NumberAF1717
Catalog NumberAF1717
Company DUNS958758146
Company NamePRIMO 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 Usefalse
Lot Batchtrue
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
GS100810006683523 [Primary]
GS110810006683520 [Package]
Contains: 00810006683523
Package: Each [12 Units]
In Commercial Distribution

FDA Product Code

FMPProtector, Skin Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-03
Device Publish Date2021-07-26

On-Brand Devices [AirFloat Static Air Seat Cushion]

10810006684121AirFloat Static Air Seat Cushion Bariatric (28"x22") with pump
10810006684114AirFloat Static Air Seat Cushion (19"x19") with pump
10810006683537AirFloat Static Air Seat Cushion (17"x17") with pump
10810006683520AirFloat Static Air Seat Cushion (17"x17")

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