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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, single-use FDA UDI
Device Name
INSTANT COLD PACKS 6" X 9" FDA UDI
Model / Reference
561111 FDA UDI
Description
INSTANT COLD PACKS 6" X 9" FDA UDI

Identifiers

Catalog Number
561111 FDA UDI
Primary DI / UDI-DI
00852244007525 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Hot/cold therapy pack, single-use

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

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kentron Health Care, Inc.

Sources (1)

  • FDA UDI 96707980-8835-43c5-a7c4-521b7b85f489 35 fields · synced Jun 1, 2026