Redicare

FDA UDI

Class I (US FDA UDI)

by Redicare Llc

Identity

Trade Name: Redicare FDA UDI
Generic Name: Hot/cold therapy pack, single-use FDA UDI
Device Name: 1 Instant Ice Pack Compress Large 5" x 8" FDA UDI
Model / Reference: Instant Ice Pack 5" x 8" FDA UDI
Description: 1 Instant Ice Pack Compress Large 5" x 8" FDA UDI

Identifiers

Catalog Number: 0107004 FDA UDI
Primary DI / UDI-DI: B70901070040 FDA UDI
FDA Product Code: IMD FDA UDI
GMDN Term: Hot/cold therapy pack, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.5710 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

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Width — 5 Inch FDA UDI
Length — 8 Inch FDA UDI

Category: Hot/cold therapy pack, single-use

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

Similar devices

Also classified as Hot/cold therapy pack, single-use.

B-COOL UNIV WRAP COLD THERAPY KIT — BIRD & CRONIN, LLC · Class I
Halyard — OWENS & MINOR DISTRIBUTION, INC. · Class I
CareStock — MCKESSON MEDICAL-SURGICAL INC. · Class I
McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
Medline — MEDLINE INDUSTRIES, INC. · Class I
McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
ASP MEDICAL — Asp Global, LLC · Class I
Medline — MEDLINE INDUSTRIES, INC. · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Redicare Llc

Sources (1)

FDA UDI b3e54400-40a0-498f-98d2-f8a1c07affed 36 fields · synced May 29, 2026