Kentex

FDA UDI

Class I (US FDA UDI)

by Kentron Health Care, Inc.

Identity

Trade Name: KENTEX FDA UDI
Generic Name: Hot/cold therapy pack, reusable FDA UDI
Device Name: GEL PACK REUSABLE 5" X 7" FDA UDI
Model / Reference: 570057 FDA UDI
Description: GEL PACK REUSABLE 5" X 7" FDA UDI

Identifiers

Catalog Number: 570057 FDA UDI
Primary DI / UDI-DI: 00852244007563 FDA UDI
FDA Product Code: IME FDA UDI
GMDN Term: Hot/cold therapy pack, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.5700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

MRI Safety

MR Safe FDA UDI

Category: Hot/cold therapy pack, reusable

Kentex by Kentron Health Care, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Hot/cold therapy pack, reusable.

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Hot Cold Pack - Universal customized Cartoon pack Jurassic & Gabby's Dollhouse — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
HOT/COLD THERAPY SLIPPER — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
PRONTO MED — Eurosirel Spa · Class IIa
HOT/COLD THERAPEUTIC PACK FOR KNEE — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
hot cold pack — Anhui Kamt Ice Pack Co.,Ltd. · Class I
HotCold Pack reusable — Bevaplast B.V. · Class I
reusable cold hot gel pack for Ankle — Wuhan Pakcare Bio‐technology Co.,Ltd. · 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

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Manufacturer

Manufacturer: Kentron Health Care, Inc.

Sources (1)

FDA UDI f4bd291b-b536-4235-9ef6-ce6fa4bfd736 35 fields · synced May 30, 2026