Redicare

FDA UDI

Class I (US FDA UDI)

by Redicare Llc

Identity

Trade Name: Redicare FDA UDI
Generic Name: Synthetic polymer burn dressing, gel-coated FDA UDI
Device Name: 1 Burn Gel Dressing 4"x4" FDA UDI
Model / Reference: Burn Gel Dressing 4" x 4" FDA UDI
Description: 1 Burn Gel Dressing 4"x4" FDA UDI

Identifiers

Catalog Number: 0114007 FDA UDI
Primary DI / UDI-DI: B70901140070 FDA UDI
FDA Product Code: NAE FDA UDI
GMDN Term: Synthetic polymer burn dressing, gel-coated FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4022 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Width — 10 Centimeter FDA UDI
Length — 10 Centimeter FDA UDI

Category: Synthetic polymer burn dressing, gel-coated

Redicare by Redicare Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Synthetic polymer burn dressing, gel-coated.

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BURNSHIELD — BURNSHIELD (PTY) LTD · U
Dukal — Dukal LLC · Class I
XeroBurn Sterile Burn Dressing Blanket 60"x 70" — Dynarex Corp. · Class I
BurnFree — WATER-JEL TECHNOLOGIES, L.L.C. · Class I
BURNSHIELD — BURNSHIELD (PTY) LTD · U

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: Redicare Llc

Sources (1)

FDA UDI 0c248888-b05a-4abc-88a2-7aa2b1c8482a 35 fields · synced May 30, 2026