Air Float Static Air Seat Cushion AF171715

GUDID 00810006680164

Air Float Static Air Seat Cushion (17"x17"x1.5")

PRIMO INC

Freestanding patient positioner, single-use
Primary Device ID00810006680164
NIH Device Record Keyae6b1283-3daf-443e-8faa-9f03d4de5360
Commercial Distribution StatusIn Commercial Distribution
Brand NameAir Float Static Air Seat Cushion
Version Model NumberAF171715
Catalog NumberAF171715
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
GS100810006680164 [Primary]

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 Date2019-03-11
Device Publish Date2019-02-20

On-Brand Devices [Air Float Static Air Seat Cushion]

00810006680188Air Float Static Air Seat Cushion Bariatric (28"x22"x1.5")
00810006680171Air Float Static Air Seat Cushion (19"x19"x1.5")
00810006680164Air Float Static Air Seat Cushion (17"x17"x1.5")

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