Enlite® Serter

GUDID 00643169246478

LANCET DEVICE MMT-7510 ENLT SNSRTR US

MEDTRONIC MINIMED, INC.

Injector reset device 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.

• 00643169976337 - Site Adhesive Sample Kit: 2024-04-12 KIT MMT-643NA SAMPLE SITE ADHESIVE EN
• 00763000791391 - CareLink™ Connect: 2024-03-29 SFTWR MMT-6111 CP ANDROID V3.2.1 OUS
• 00763000910143 - MiniMed ™ Mobile: 2024-03-18 SFTWR MMT-6101 AHCL APP 2.5 ANDROID
• 00763000910150 - MiniMed™ Mobile: 2024-03-18 SFTWR MMT-6102 AHCL APP 2.5 IOS
• 20763000837215 - Extended™ Reservoir 3.0mL: 2024-02-26 RSVR MMT-342G 5PK EW 3ML US
• 20763000837239 - Extended™ Reservoir: 2024-02-20 RSVR MMT-342G 5PK EW 3ML US
• 00763000837259 - Extended Reservoir™: 2024-02-20 RSVR MMT-342G 5PK EW 3ML US
• 00763000910082 - MiniMed™ 780G: 2024-02-12 PUMP MMT-1884L MM780G MG 6.21 A1.01 PRB