ROHO ENHANCER Cushion

GUDID 00613732114268

Roho, Inc.

Air-filled chair cushion
Primary Device ID00613732114268
NIH Device Record Keyd0120ac8-39fb-422f-9dd2-5041e24f4dc6
Commercial Distribution StatusIn Commercial Distribution
Brand NameROHO ENHANCER Cushion
Version Model NumberENH1012C
Company DUNS006614792
Company NameRoho, 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 Batchfalse
Serial Numbertrue
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
GS100613732114268 [Primary]

FDA Product Code

KICCushion, Flotation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-24
Device Publish Date2025-03-15

On-Brand Devices [ROHO ENHANCER Cushion]

00613732057268ENHDEMO
00613732056810ENH1011C
00613732053338ENHMODIFIED
00613732037314ENH1110C
00613732001148ENH99C
00613732001117ENH99DMC
00613732001094ENH98C
00613732001063ENH910C
00613732001025ENH89C
00613732000974ENH88C
00613732000868ENH109C
00613732000837ENH109DMC
00613732000813ENH1010C
00613732000790ENH1010DMC
00613732000776ENHSMC
00613732000745ENHLGC
00613732000691ENHCUSTC
00613732114268ENH1012C
00613732114244ENH810C
00613732113674ENH911C
00613732113650ENH1111C

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