AccessGUDID - DEVICE: Therm-X (00850001096324)

GUDID

Device Identifier (DI) Information

Brand Name: Therm-X
Version or Model: Therm-X Hand SPU
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TX0312
Company Name: ZENITH TECHNICAL INNOVATIONS, LLC

Primary DI Number: 00850001096324
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 062931546 *Terms of Use

Device Description: Therm-X Hand SPU

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IRP	Massager, Powered Inflatable Tube
JOW	Sleeve, Limb, Compressible
ILO	Pack, Hot Or Cold, Water Circulating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K231912	000
K240125	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 33 and 102 Degrees Fahrenheit
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: less than 60 Percent (%) Relative Humidity
Storage Environment Humidity: less than 60 Percent (%) Relative Humidity
Handling Environment Temperature: between 33 and 122 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 14b6ee98-2d16-4a3a-a8eb-f0d5ed0e1e9a
Public Version Date: August 08, 2024
Public Version Number: 1
DI Record Publish Date: July 31, 2024