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Bosma Enterprises

FDA UDI

Class I (US FDA UDI)

by Bosma Enterprises

Identity

Trade Name
Bosma Enterprises FDA UDI
Generic Name
Patient transfer/turning sheet, single-use FDA UDI
Device Name
Accelerate-OR Women's GAW Kit: Each Kit Includes 40x80 Disposable XL Lift Sheet, Patient Gown 72x45, Disposable Underpad 23x36, and Sterilization Paper Liner 20x25 FDA UDI
Model / Reference
10-8020GAW FDA UDI
Description
Accelerate-OR Women's GAW Kit: Each Kit Includes 40x80 Disposable XL Lift Sheet, Patient Gown 72x45, Disposable Underpad 23x36, and Sterilization Paper Liner 20x25 FDA UDI

Identifiers

Catalog Number
10-8020GAW FDA UDI
Primary DI / UDI-DI
00818634025531 FDA UDI
FDA Product Code
PWU FDA UDI
GMDN Term
Patient transfer/turning sheet, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6890 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

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

Category: Absorbent underpad, non-antimicrobial, single-usePatient gown, single-usePatient transfer/turning sheet, single-useSterilization container liner

Bosma Enterprises by Bosma Enterprises — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sterilization container liner.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bosma Enterprises

Sources (1)

  • FDA UDI a6acc606-9b60-4c90-a30a-7954b66273fb 36 fields · synced May 30, 2026