MiniMed® 630G

GUDID 00763000075439

PUMP MMT-1715KR 630G V2.8 SF MG RECERT

MEDTRONIC MINIMED, INC.

Ambulatory insulin infusion pump, electronic

• Primary Device ID: 00763000075439
• NIH Device Record Key: b9537eb1-044b-481a-93cd-bbf13d9c2e4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiniMed® 630G
• Version Model Number: MMT-1715KR
• Company DUNS: 849626338
• Company Name: MEDTRONIC MINIMED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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
• 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 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000075439 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150001

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: 4
• Public Version Date: 2018-09-12
• Device Publish Date: 2018-02-23

On-Brand Devices [MiniMed® 630G]

• 00643169878648: KIT MMT-1755KMK 630G 3ML V2.8 BK EN A^
• 00643169873841: KIT MMT-1755KM 630G 3ML V2.8 BK EN A^
• 00643169873834: PUMP MMT-1715KM 630G V2.8 BK SF MG
• 00643169752726: KIT MMT-1755K 630G 3ML V2.8 BK EN
• 00643169656840: PUMP MMT-1715K 630G V2.8 BK SF MG
• 00763000179632: KIT MMT-1755KR 630G 3ML V4.10 EN RECERT
• 00763000173036: PUMP MMT-1715KR 630G V4.10 SF MG RECERT
• 00763000166519: PUMP MMT-1715KL 630G V4.10 BK SF MG
• 00763000157043: KIT MMT-1755K 630G V4.10 EN MG
• 00763000075446: KIT MMT-1755KR 630G 3ML V2.8 EN RECERT
• 00763000075439: PUMP MMT-1715KR 630G V2.8 SF MG RECERT
• 00763000072520: PUMP MMT-1715KL 630G V2.8 BK SF MG
• 00763000256814: PUMP MMT-1715KR 630G V4.11 JBL MG RECERT
• 00763000256807: PUMP MMT-1715KL 630G V4.11 JBL MG
• 00763000316686: PUMP MMT-1715KR 630G V4.11 JBL MG RECERT
• 00763000316679: PUMP MMT-1715KR 630G V4.10 BM MG RECERT
• 00763000316662: PUMP MMT-1715KM 630G V4.11 JBL MG
• 00763000316655: PUMP MMT-1715KL 630G V4.11 JBL MG
• 00763000316648: PUMP MMT-1715KL 630G V4.10 BM MG
• 00763000316631: PUMP MMT-1715K 630G V4.11 JBL MG
• 00763000190446: KIT MMT-1755K 630G V4.11 EN MG
• 00763000190439: PUMP MMT-1715K 630G V4.11 BK SF MG
• 00763000367060: PUMP MMT-1715KR 630G V4.11 JBL MG RECERT
• 00763000367053: PUMP MMT-1715KL 630G V4.11 JBL MG