Tempo Smart Button MS6303

GUDID 00300020911554

Reusable connected data transfer module.

ELI LILLY AND COMPANY

Patient monitoring system module, data memory

• Primary Device ID: 00300020911554
• NIH Device Record Key: d22d4ec8-b8f0-4658-ba70-c7fbde2bacd5
• Commercial Distribution Discontinuation: 2026-11-25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tempo Smart Button
• Version Model Number: MS6303
• Catalog Number: MS6303
• Company DUNS: 006421325
• Company Name: ELI LILLY AND COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18555455983
• Email: xxx@xxx.xxx
• Phone: 18555455983
• Email: xxx@xxx.xxx
• Phone: 18555455983
• Email: xxx@xxx.xxx
• Phone: 18555455983
• Email: xxx@xxx.xxx
• Phone: 18555455983
• Email: xxx@xxx.xxx
• Phone: 18555455983
• Email: xxx@xxx.xxx
• Phone: 18555455983
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00300020911554 [Primary]
GS1	30300020911555 [Package]; Package: Carton [1 Units]; Discontinued: 2026-11-25; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212217

FDA Product Code

• QOG: Injection Data Capture Device

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: 2026-03-18
• Device Publish Date: 2022-11-01

Devices Manufactured by ELI LILLY AND COMPANY

• 00300020911554 - Tempo Smart Button: 2026-03-18Reusable connected data transfer module.
• 00300020911554 - Tempo Smart Button: 2026-03-18 Reusable connected data transfer module.
• 30300020948551 - Tempo Welcome Kit: 2026-03-18 Convenience Kit for patients with diabetes. Contains Tempo Smart Button, lancets, testing strips, and BD needles.
• 00300021451554 - Lilly Together: 2025-04-25 Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support
• 00300021458553 - Lilly Together: 2025-04-25 Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support
• 00300021285555 - Lilly Together: 2024-12-04 Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support
• 00300021286552 - Lilly Together: 2024-12-04 Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support
• 00300021283551 - Lilly Together: 2024-08-05 Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support
• 00300021284558 - Lilly Together: 2024-08-05 Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support