TraxIt TXT C

GUDID 20016944701082

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

MEDICAL INDICATORS INC

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• Primary Device ID: 20016944701082
• NIH Device Record Key: 6b749bf3-b773-4bf0-a163-990a489b76d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TraxIt
• Version Model Number: 2313
• Catalog Number: TXT C
• Company DUNS: 030104165
• Company Name: MEDICAL INDICATORS INC
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Dimensions

• Weight: 0.00123 Pound
• Weight: 0.00123 Pound
• Weight: 0.00123 Pound
• Weight: 0.00123 Pound
• Weight: 0.00123 Pound
• Weight: 0.00123 Pound
• Weight: 0.00123 Pound
• Weight: 0.00123 Pound
• Weight: 0.00123 Pound
• Weight: 0.00123 Pound
• Weight: 0.00123 Pound
• Weight: 0.00123 Pound
• Weight: 0.00123 Pound
• Weight: 0.00123 Pound
• Weight: 0.00123 Pound
• Weight: 0.00123 Pound
• Weight: 0.00123 Pound

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00016944701088 [Primary]
GS1	10016944701085 [Unit of Use]
GS1	20016944701082 [Package]; Contains: 00016944701088; Package: Case [2000 Units]; In Commercial Distribution

FDA Product Code

• FQZ: Thermometer, Clinical Color Change

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-08-23
• Device Publish Date: 2021-05-29

On-Brand Devices [TraxIt]

• 10016944701092: TraxIt F DTC Wearable Children's Underarm Single-use Thermometer (48-Hour Continuous Monitoring)
• 20016944701099: TraxIt F Wearable Children's Underarm Disposable Clinical Thermometer
• 20016944701082: TraxIt C Wearable Children's Underarm Single-use Thermometer (48-Hour Continuous Monitoring)