KENTEX

Basic Information

• Brand Name: KENTEX
• Primary DI: 00852244007563
• Version / Model: 570057
• Catalog Number: 570057
• Company Name: KENTRON HEALTHCARE, INC.
• Labeler DUNS: 618825723
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-27
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: f4bd291b-b536-4235-9ef6-ce6fa4bfd736

Device Description

GEL PACK REUSABLE 5" X 7"

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IME	Pack, Hot Or Cold, Reuseable	Physical Medicine	890.5700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37240	Hot/cold therapy pack, reusable	A non-sterile device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10852244007560	GS1		24	In Commercial Distribution
Primary	00852244007563	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]