Tempo

GUDID 10885325001416

Tempo Blood Glucose Test Strip

i-SENS, Inc.

Glucose IVD, reagent

• Primary Device ID: 10885325001416
• NIH Device Record Key: bde39db0-129a-4ce2-bcd6-8de09de5bb8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tempo
• Version Model Number: 343104
• Company DUNS: 688840958
• Company Name: i-SENS, Inc.
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885325001419 [Primary]
GS1	10885325001416 [Package]; Contains: 00885325001419; Package: Case Pack [50 Units]; In Commercial Distribution
GS1	20885325001413 [Package]; Package: Master Case Carton [10 Units]; In Commercial Distribution
GS1	50885325001414 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192859

FDA Product Code

• CGA: Glucose Oxidase, Glucose

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-25
• Device Publish Date: 2021-02-17

On-Brand Devices [Tempo]

• 10885325001423: Tempo Blood Glucose Test Strip
• 10885325001416: Tempo Blood Glucose Test Strip
• 10885325001409: Tempo Blood Glucose Monitoring System
• 10885325001386: Tempo Blood Glucose Monitoring System