Enlite™ Serter

GUDID 00613994933072

LANCET DEVICE MMT-7510 SNSRTR ENLT 23L

MEDTRONIC MINIMED, INC.

Injector reset device

• Primary Device ID: 00613994933072
• NIH Device Record Key: c21c4535-bc83-44db-8f8d-8f343f14ab0a
• 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: MR Safe
• 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	00613994933072 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P120010

FDA Product Code

• OZO: Artificial pancreas device system, threshold suspend

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: 2016-08-14

On-Brand Devices [Enlite™ Serter]

• 00613994933072: LANCET DEVICE MMT-7510 SNSRTR ENLT 23L
• 00643169462724: LANCET DEVICE MMT-7510 ENLT SNSRTR 2L