Therm-X

Basic Information

• Brand Name: Therm-X
• Primary DI: 00850001096065
• Version / Model: Therm-X Shoulder Garment
• Catalog Number: TX0101
• Company Name: ZENITH TECHNICAL INNOVATIONS, LLC
• Labeler DUNS: 062931546
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-17
• Public Version: 3
• Public Version Date: 2019-05-22
• Public Version Status: Update
• Public Device Record Key: bcf0aba5-d0a7-482b-b78c-0b9322239dfa

Device Description

Therm-X Shoulder Garment

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
JOW	Sleeve, Limb, Compressible	Cardiovascular	870.5800	2
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	890.5720	2
IRP	Massager, Powered Inflatable Tube	Physical Medicine	890.5650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61429	Inflatable hot/cold therapy pack/electric pump	A non-sterile assembly of devices intended for localized thermal and compression therapy to facilitate the treatment of a variety of adverse conditions resulting from musculoskeletal injury (e.g., pain, swelling, inflammation). It includes one or more hot and/or cold therapy packs with an air inflation sleeve, a mains electricity (AC-powered) air pump with controls, and air-conduction tubing; the pack(s) is heated/cooled independently of the system (e.g., cooled using chilling unit) and may be anatomically specific. The unit may be programmed for selected treatment plans. It is intended for use in both professional and home settings.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850001096065	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 33 – 122 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 33 – 122 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: – 60 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: – 60 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal