NexTemp NXT Ultra C

GUDID 20016944401104

NexTemp Ultra C Single-use Clinical Thermometer

MEDICAL INDICATORS INC

Liquid-crystal patient thermometer, single-use

• Primary Device ID: 20016944401104
• NIH Device Record Key: 4b80206e-1c4a-46f1-bdb2-fd346bb489c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NexTemp
• Version Model Number: 8200
• Catalog Number: NXT Ultra 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: 0.0015 Pound
• Weight: 0.0015 Pound
• Weight: 0.0015 Pound
• Weight: 0.0015 Pound
• Weight: 0.0015 Pound
• Weight: 0.0015 Pound
• Weight: 0.0015 Pound
• Weight: 0.0015 Pound
• Weight: 0.0015 Pound
• Weight: 0.0015 Pound
• Weight: 0.0015 Pound
• Weight: 0.0015 Pound
• Weight: 0.0015 Pound
• Weight: 0.0015 Pound
• Weight: 0.0015 Pound
• Weight: 0.0015 Pound
• Weight: 0.0015 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	00016944401100 [Primary]
GS1	10016944401107 [Unit of Use]
GS1	20016944401104 [Package]; Contains: 00016944401100; 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

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• 20016944401104: NexTemp Ultra C Single-use Clinical Thermometer
• 20016944401067: NexTemp Plus F Disposable Clinical Thermometer with rectal sheath
• 20016944401036: NexTemp F Single use Clinical Thermometer
• 20016944401029: NexTemp US C Single-use Clinical Thermometer
• 10016944401176: NexTemp Ultra Pro F Bulk Pack Clinical Thermometer