Tempo Refill Kit MC0002001AM

GUDID 50300021151558

Tempo Refill Kit - This is a convenience kit which contains multiple devices with different counts: Lancets/Strips/BD needles and gauze pads.

ELI LILLY AND COMPANY

Glucose monitoring system IVD, home-use

• Primary Device ID: 50300021151558
• NIH Device Record Key: cd2d5795-9b78-478d-aef1-e1f5015cc2f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tempo Refill Kit
• Version Model Number: MC0002
• Catalog Number: MC0002001AM
• Company DUNS: 006421325
• Company Name: ELI LILLY AND COMPANY
• Device Count: 1
• 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: false
• Lot Batch: true
• Serial Number: true
• 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

Customer Support Contacts

• Phone: 1-855-545-5983
• Email: xx@xxx.xxx
• Phone: 1-855-545-5983
• Email: xx@xxx.xxx
• Phone: 1-855-545-5983
• Email: xx@xxx.xxx
• Phone: 1-855-545-5983
• Email: xx@xxx.xxx
• Phone: 1-855-545-5983
• Email: xx@xxx.xxx
• Phone: 1-855-545-5983
• Email: xx@xxx.xxx
• Phone: 1-855-545-5983
• Email: xx@xxx.xxx
• Phone: 1-855-545-5983
• Email: xx@xxx.xxx
• Phone: 1-855-545-5983
• Email: xx@xxx.xxx
• Phone: 1-855-545-5983
• Email: xx@xxx.xxx
• Phone: 1-855-545-5983
• Email: xx@xxx.xxx
• Phone: 1-855-545-5983
• Email: xx@xxx.xxx
• Phone: 1-855-545-5983
• Email: xx@xxx.xxx

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00300021151553 [Primary]
GS1	50300021151558 [Package]; Contains: 00300021151553; Package: Carton [18 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212217

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

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: 2023-09-05
• Device Publish Date: 2023-08-28

On-Brand Devices [Tempo Refill Kit]

• 30300020947554: Tempo Refill Kit - Convenience Kit for patients with diabetes, which contains lancets, testing s
• 50300021151558: Tempo Refill Kit - This is a convenience kit which contains multiple devices with different coun