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First Responder

FDA UDI

Class I (US FDA UDI)

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

Identity

Trade Name
First Responder FDA UDI
Generic Name
Pure wool burn sheet FDA UDI
Device Name
First Responder Burn Wrap 3'x2.5', 4 Pouches/cs; BD Gel HA FDA UDI
Model / Reference
G3630P-4.00.000 FDA UDI
Description
First Responder Burn Wrap 3'x2.5', 4 Pouches/cs; BD Gel HA FDA UDI

Identifiers

Catalog Number
G3630P-4.00.000 FDA UDI
Primary DI / UDI-DI
00743537000074 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

First Responder 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 8d6a850f-7e24-42c8-a2b9-0541d285dc29 35 fields · synced May 30, 2026