Jay Union Cushion

FDA UDI

Class I (US FDA UDI)

by Sunrise Medical (US) LLC

Identity

Trade Name: Jay Union Cushion FDA UDI
Generic Name: Gel-filled chair cushion FDA UDI
Device Name: The JAY Union is a versatile, comfortable, skin protection and positioning wheelchair cushion composed of a dynamic fluid and foam layering system. FDA UDI
Model / Reference: Jay Union Cushion FDA UDI
Description: The JAY Union is a versatile, comfortable, skin protection and positioning wheelchair cushion composed of a dynamic fluid and foam layering system. FDA UDI

Identifiers

Catalog Number: E2607, E2608 FDA UDI
Primary DI / UDI-DI: 00016958056402 FDA UDI
FDA Product Code: IMP FDA UDI
GMDN Term: Gel-filled chair cushion FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3920 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Gel-filled chair cushion

Jay Union Cushion by Sunrise Medical (US) LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Gel-filled chair cushion.

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Ever-Soft Gel Foam Cushion — Dynarex Corp. · Class I
Drive — Drive Devilbiss Healthcare · Class I
Everest & Jennings — GF Health Products, Inc · Class I
DRIVE — Drive Devilbiss Healthcare · Class I
Everest & Jennings — GF Health Products, Inc · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Sunrise Medical (US) LLC

Sources (1)

FDA UDI 37c8c504-304b-4409-b623-005459a949e1 34 fields · synced Jun 9, 2026