Drivemedical

FDA UDI

Class I (US FDA UDI)

by Drive Devilbiss Healthcare

Identity

Trade Name: DRIVEMEDICAL FDA UDI
Generic Name: Foam-filled chair cushion FDA UDI
Device Name: Pressure PreventionSeat and Back Cushions Product Description: PremierOneFoamCushion 20x16x3" 1 ea,4/CS FDA UDI
Model / Reference: M8065 FDA UDI
Description: Pressure PreventionSeat and Back Cushions Product Description: PremierOneFoamCushion 20x16x3" 1 ea,4/CS FDA UDI

Identifiers

Primary DI / UDI-DI: 00822383514482 FDA UDI
FDA Product Code: KIC FDA UDI
IMP FDA UDI
GMDN Term: Foam-filled chair cushion FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3175 FDA UDI
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

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

FDA UDI

Category: Foam-filled chair cushion

Drivemedical by Drive Devilbiss Healthcare — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Drive Devilbiss Healthcare

Sources (1)

FDA UDI 3340a6c5-9d10-4f23-b0f3-aca7679c9cda 33 fields · synced Jun 8, 2026