One-press Serter

GUDID 00763000341923

SERTER MMT-7512N IIN GENERIC 2L

MEDTRONIC MINIMED, INC.

Injector reset device

• Primary Device ID: 00763000341923
• NIH Device Record Key: b95058c6-5ec6-404e-92d4-c918cda06274
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: One-press Serter
• Version Model Number: MMT-7512N
• Company DUNS: 849626338
• Company Name: MEDTRONIC MINIMED, INC.
• Device Count: 1
• DM Exempt: false
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000341923 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160017

FDA Product Code

• OZO: Automated insulin dosing , threshold suspend

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: 2020-05-25
• Device Publish Date: 2020-05-16

On-Brand Devices [One-press Serter]

• 00643169980525: SERTER MMT-7512N 1CLK GENERIC 2L
• 00763000341930: SERTER MMT-7512NA IIN 1CLK US
• 00763000341923: SERTER MMT-7512N IIN GENERIC 2L
• 00763000859206: SERTER MMT-7512G IIN 1CLK G4S US 3L