HumaPen® Luxura™ HD - SAMPLE MS9675

GUDID 30300029675014

HumaPen Luxura HD is a reusable pen injector intended for use with Lilly 3 mL insulin cartridges. Designated for sample use.

ELI LILLY AND COMPANY

Cartridge-accepting autoinjector, mechanical

• Primary Device ID: 30300029675014
• NIH Device Record Key: 316a786a-7683-486a-92fe-cbf5cfae6b68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HumaPen® Luxura™ HD - SAMPLE
• Version Model Number: MS9675
• Catalog Number: MS9675
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 1-800-545-5979
• Email: xxx@xxx.xxx
• Phone: 1-800-545-5979
• Email: xxx@xxx.xxx
• Phone: 1-800-545-5979
• Email: xxx@xxx.xxx
• Phone: 1-800-545-5979
• Email: xxx@xxx.xxx
• Phone: 1-800-545-5979
• Email: xxx@xxx.xxx
• Phone: 1-800-545-5979
• Email: xxx@xxx.xxx
• Phone: 1-800-545-5979
• Email: xxx@xxx.xxx
• Phone: 1-800-545-5979
• Email: xxx@xxx.xxx
• Phone: 1-800-545-5979
• Email: xxx@xxx.xxx
• Phone: 1-800-545-5979
• Email: xxx@xxx.xxx
• Phone: 1-800-545-5979
• Email: xxx@xxx.xxx
• Phone: 1-800-545-5979
• Email: xxx@xxx.xxx
• Phone: 1-800-545-5979
• Email: xxx@xxx.xxx
• Phone: 1-800-545-5979
• Email: xxx@xxx.xxx
• Phone: 1-800-545-5979
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00300029675013 [Primary]
GS1	30300029675014 [Package]; Contains: 00300029675013; Package: Case [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100988

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-25

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• 00300021176556 - Lilly Together: 2024-03-19 Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support
• 00300021177553 - Lilly Together: 2024-03-19 Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support
• 00300021174552 - Lilly Together: 2024-02-26 Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support
• 00300021175559 - Lilly Together: 2024-02-26 Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support
• 50300021151558 - Tempo Refill Kit: 2023-09-05 Tempo Refill Kit - This is a convenience kit which contains multiple devices with different counts: Lancets/Strips/BD needles an
• 30300020947554 - Tempo Refill Kit: 2023-08-24 Tempo Refill Kit - Convenience Kit for patients with diabetes, which contains lancets, testing strips, and BD needles.