AccessGUDID - DEVICE: Therm-X (00850001096294)

GUDID

Device Identifier (DI) Information

Brand Name: Therm-X
Version or Model: Therm-X AT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TX0002
Company Name: ZENITH TECHNICAL INNOVATIONS, LLC

Primary DI Number: 00850001096294
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 062931546 *Terms of Use

Device Description: Therm-X AT

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181149	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 122 Degrees Fahrenheit
Handling Environment Temperature: between 33 and 122 Degrees Fahrenheit
Storage Environment Humidity: less than 60 Percent (%) Relative Humidity
Handling Environment Humidity: less than 60 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b71dd7b1-3f93-4825-baa1-8593bdd9069d
Public Version Date: August 01, 2024
Public Version Number: 2
DI Record Publish Date: March 07, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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