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BurnFree

FDA UDI

Class I (US FDA UDI)

by Water-Jel Technologies, L.l.c.

Identity

Trade Name
BurnFree FDA UDI
Generic Name
Pure wool burn sheet FDA UDI
Device Name
Int'l BurnFree 36"X30", 91x76cm Fire/Trauma Blanket FDA UDI
Model / Reference
SB-9176.00.000 FDA UDI
Description
Int'l BurnFree 36"X30", 91x76cm Fire/Trauma Blanket FDA UDI

Identifiers

Catalog Number
SB-9176.00.000 FDA UDI
Primary DI / UDI-DI
00743537000012 FDA UDI
FDA Product Code
FPY FDA UDI
GMDN Term
Pure wool burn sheet FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5180 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Pure wool burn sheet

BurnFree by Water-Jel Technologies, L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pure wool burn sheet.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Water-Jel Technologies, L.l.c.

Sources (1)

  • FDA UDI 74cb75b1-6926-4742-adfa-d011762a594b 35 fields · synced Jun 1, 2026