Enlite® Serter

GUDID 00643169246478

LANCET DEVICE MMT-7510 ENLT SNSRTR US

MEDTRONIC MINIMED, INC.

Injector reset device

• Primary Device ID: 00643169246478
• NIH Device Record Key: 241c5721-0642-49f0-821a-4b64c8acabe1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enlite® Serter
• Version Model Number: MMT-7510
• Company DUNS: 849626338
• Company Name: MEDTRONIC MINIMED, INC.
• Device Count: 1
• DM Exempt: true
• 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)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169246478 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P120010

FDA Product Code

• CGA: GLUCOSE OXIDASE, GLUCOSE

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: 2014-09-24

Devices Manufactured by MEDTRONIC MINIMED, INC.

• 00763000974589 - InPen: 2025-05-07 SW MMT-8060 INPEN 2.0 IOS APP US
• 00763000974596 - InPen: 2025-05-07 SW MMT-8061 INPEN 2.0 ANDROID APP US
• 00763000565039 - Medtronic Simplera™ Sensor: 2025-03-25 SENSOR MMT-5100JB SIMPLERA 1PK US
• 00763000565022 - Simplera™ Sensor: 2025-03-25 SENSOR MMT-5100JA SIMPLERA 5PK US
• 00763000565046 - Medtronic Simplera™ Sensor: 2025-03-25 KIT MMT-5101N SIMPLERA 5PK US
• 00763000829575 - Simplera™ Sensor: 2025-03-25 SENSOR MMT-5100JPA SIM 5PK PHARM US
• 00763000829650 - Simplera™ Sensor: 2025-03-25 KIT MMT-5101PN SIMPLERA 5PK PHARM US
• 00763000489953 - InPen Smart Insulin Delivery System: 2025-03-17 SOFTWARE MMT-8060 INSULIN PEN IOS APP