Jay Union Cushion E2607, E2608

GUDID 00016958056402

The JAY Union is a versatile, comfortable, skin protection and positioning wheelchair cushion composed of a dynamic fluid and foam layering system.

SUNRISE MEDICAL (US) LLC

Gel-filled chair cushion
Primary Device ID00016958056402
NIH Device Record Key37c8c504-304b-4409-b623-005459a949e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameJay Union Cushion
Version Model NumberJay Union Cushion
Catalog NumberE2607, E2608
Company DUNS962525056
Company NameSUNRISE MEDICAL (US) LLC
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100016958056402 [Primary]

FDA Product Code

IMPCushion, Wheelchair

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-20
Device Publish Date2021-05-12

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