AccessGUDID - DEVICE: TraxIt (00016944701514)

GUDID

Device Identifier (DI) Information

Brand Name: TraxIt
Version or Model: 2313-12
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TXT C
Company Name: MEDICAL INDICATORS INC

Primary DI Number: 00016944701514
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 030104165 *Terms of Use

Device Description: TraxIt C DTC Wearable Children's Underarm Single-use Thermometer (48-Hour Continuous Monitoring)

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
33618	Liquid-crystal patient thermometer, single-use	A device designed to measure a patient's skin, oral, rectal, or axillary (armpit) body temperature. It uses liquid-crystal sensors (usually formed from esters of cholesterol) that are sealed in a plastic band and appear to change colour at indicated temperatures. The device may be used in the home. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQZ	Thermometer, Clinical Color Change

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: less than 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 0.00123 Pound

Device Record Status

Public Device Record Key: 0ed05727-a8c8-4fff-b486-a3135845aa8e
Public Version Date: May 16, 2025
Public Version Number: 1
DI Record Publish Date: May 08, 2025