inpen™

GUDID 00763000827168

KIT MMT-105ELGYNA INPEN ELI LILLY GREY

MEDTRONIC MINIMED, INC.

Empty self-injector, mechanical

• Primary Device ID: 00763000827168
• NIH Device Record Key: 88db7c34-c851-4dcc-b6d1-4144bfc86bb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: inpen™
• Version Model Number: MMT-105ELGYNA
• Company DUNS: 849626338
• Company Name: MEDTRONIC MINIMED, INC.
• 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: false
• Serial Number: true
• 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)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000827168 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201337

FDA Product Code

• FMF: Syringe, piston

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: 2024-06-10
• Device Publish Date: 2024-05-31

On-Brand Devices [inpen™]

• 00763000827175: KIT MMT-105ELPKNA INPEN ELI LILLY PINK
• 00763000827168: KIT MMT-105ELGYNA INPEN ELI LILLY GREY
• 00763000827151: KIT MMT-105ELBLNA INPEN ELI LILLY BLUE
• 00763000827205: KIT MMT-105NNPKNA INPEN NOVONORDISK PINK
• 00763000827199: KIT MMT-105NNGYNA INPEN NOVONORDISK GREY
• 00763000827182: KIT MMT-105NNBLNA INPEN NOVONORDISK BLUE