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FDA UDI

Class I (US FDA UDI)

by Drive Devilbiss Healthcare

Identity

Trade Name
Drive FDA UDI
Generic Name
Waterproof bed mattress cover, reusable FDA UDI
Device Name
MattressCvr,Zipper80x36,12/cs, RTL FDA UDI
Model / Reference
3861-MED FDA UDI
Description
MattressCvr,Zipper80x36,12/cs, RTL FDA UDI

Identifiers

Primary DI / UDI-DI
00822383522692 FDA UDI
FDA Product Code
FMW FDA UDI
GMDN Term
Waterproof bed mattress cover, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6190 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI d8d43eca-3193-40e5-a8e9-738d96f5ee02 34 fields · synced Jun 8, 2026