ROHO HIGH PROFILE Single Compartment Cushion

GUDID 00613732005023

Roho, Inc.

Air-filled chair cushion Air-filled chair cushion Air-filled chair cushion Air-filled chair cushion Air-filled chair cushion Air-filled chair cushion Air-filled chair cushion Air-filled chair cushion Air-filled chair cushion Air-filled chair cushion Air-filled chair cushion
Primary Device ID00613732005023
NIH Device Record Keyaeffd6f0-5808-41a2-bd22-f0722f72ccfe
Commercial Distribution StatusIn Commercial Distribution
Brand NameROHO HIGH PROFILE Single Compartment Cushion
Version Model Number1RLGC
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
GS100613732005023 [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 Date2022-11-28
Device Publish Date2022-11-18

On-Brand Devices [ROHO HIGH PROFILE Single Compartment Cushion]

006137320053371R1011C
006137320052451R1010C
006137321022891R139C
006137321022721R1014C
006137321022651R912C
006137321022581R811C
006137320939761R149C
006137320939691R148C
006137320939521R1414C
006137320939451R1413C
006137320939381R1412C
006137320939211R1410C
006137320939141R138C
006137320939071R1314C
006137320938911R128C
006137320938841R1214C
006137320938771R118C
006137320938601R1114C
006137320932351R1313C
006137320932281R1312C
006137320932111R1213C
006137320932041R1113C
006137320931981R1013C
006137320877841R1011H-CA-SR
006137320877771R1010H-CA-SR
006137320862131R911HD
006137320862061R1211HD
006137320861901R1210HD
006137320799251R1111HD
006137320799181R1110HD
006137320754531R1011HD
006137320754461R1010HD
006137320754391R109HD
006137320754221R910HD
006137320754151R99HD
006137320610501R129C
006137320610431R1212C
006137320610361R1211C
006137320610291R1112C
006137320610121R1012C
006137320538951R1511C
006137320538881R1411C
006137320538711R1311C
006137320538641R1310C
006137320373071R1210C
006137320372911R1111C
006137320066621R99C
006137320065871R98C
006137320065251R911C
006137320064331R910C

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