PARADIGM® REAL-time

GUDID 00613994229922

PUMP MMT-522PNAB PRDGM INS BL EN ML PR

MEDTRONIC MINIMED, INC.

Ambulatory insulin infusion pump, electronic

• Primary Device ID: 00613994229922
• NIH Device Record Key: cdf4f1d6-ab92-4b56-a7b3-e1d92f433aea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PARADIGM® REAL-time
• Version Model Number: MMT-522PNAB
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994229922 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P980022

FDA Product Code

• MDS: Sensor, glucose, invasive

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: 2014-09-24

On-Brand Devices [PARADIGM® REAL-time]

• 00613994623935: PUMP MMT-722RNAS PRDGM V2.4 SK EN RC
• 00613994623928: PUMP MMT-722RNAP PRDGM V2.4 PL EN RC
• 00613994623911: PUMP MMT-722RNAL PRDGM V2.4 CL EN RC
• 00613994623904: PUMP MMT-722RNAH PRDGM V2.4 PK EN RC
• 00613994623898: PUMP MMT-722RNAB PRDGM V2.4 BL EN RC
• 00613994623591: PUMP MMT-522RNAS PRDGM V2.4 SK EN RC
• 00613994623584: PUMP MMT-522RNAP PRDGM V2.4 PL EN RC
• 00613994623577: PUMP MMT-522RNAL PRDGM V2.4 CL EN RC
• 00613994623560: PUMP MMT-522RNAH PRDGM V2.4 PK EN RC
• 00613994623553: PUMP MMT-522RNAB PRDGM V2.4 BL EN RC
• 00613994622693: PUMP MMT-522NAB PRDGM INS V2.4 BL EN PR
• 00613994622686: PUMP MMT-522NAH PRDGM INS V2.4 PK EN PR
• 00613994622679: PUMP MMT-522NAL PRDGM INS V2.4 CL EN PR
• 00613994622662: PUMP MMT-522NAP PRDGM INS V2.4 PL EN PR
• 00613994622655: PUMP MMT-522NAS PRDGM INS V2.4 SK EN PR
• 00613994622594: PUMP MMT-722NAB PRDGM INS V2.4 BL EN PR
• 00613994622587: PUMP MMT-722NAH PRDGM INS V2.4 PK EN PR
• 00613994622570: PUMP MMT-722NAL PRDGM INS V2.4 CL EN PR
• 00613994622563: PUMP MMT-722NAP PRDGM INS V2.4 PL EN PR
• 00613994622556: PUMP MMT-722NAS PRDGM INS V2.4 SK EN PR
• 00613994597748: PUMP MMT-722NAH PRDGM INS V2.4 PK EN
• 00613994597243: PUMP MMT-722PNAH PRDGM V2.4 PK EN PW
• 00613994597236: PUMP MMT-722LNAH PRDGM V2.4 PK EN LN
• 00613994597229: PUMP MMT-522PNAH PRDGM V2.4 PK EN PW
• 00613994597212: PUMP MMT-522LNAH PRDGM V2.4 PK EN LN
• 00613994596499: PUMP MMT-722RNAH PRDGM V2.4 PK EN RC
• 00613994596482: PUMP MMT-522RNAH PRDGM V2.4 PK EN RC
• 00613994575296: PUMP MMT-722KNH PRDGM PED INS V1.1 PK EN
• 00613994575289: PUMP MMT-522KNH PRDGM PED INS V1.1 PK EN
• 00613994551047: PUMP MMT-722NAS PRDGM INS V2.4 SK EN LK
• 00613994453020: PUMP MMT-722NAH PRDGM INS V2.4 PK EN
• 00613994409553: PUMP MMT-722LNAS PRDGM V2.4 SK EN LK LN
• 00613994409546: PUMP MMT-722LNAP PRDGM V2.4 PL EN LK LN
• 00613994409539: PUMP MMT-722LNAL PRDGM V2.4 CL EN LK LN
• 00613994409522: PUMP MMT-722LNAB PRDGM V2.4 BL EN LK LN
• 00613994409225: PUMP MMT-722PNAB PRDGM V2.4 BL EN LK PW
• 00613994409218: PUMP MMT-722PNAL PRDGM V2.4 CL EN LK PW
• 00613994409201: PUMP MMT-722PNAP PRDGM V2.4 PL EN LK PW
• 00613994409195: PUMP MMT-722PNAS PRDGM V2.4 SK EN LK PW
• 00613994409188: PUMP MMT-722RNAB PRDGM V2.4 BL EN LK RC
• 00613994409171: PUMP MMT-722RNAL PRDGM V2.4 CL EN LK RC
• 00613994409164: PUMP MMT-722RNAP PRDGM V2.4 PL EN LK RC
• 00613994409157: PUMP MMT-722RNAS PRDGM V2.4 SK EN LK RC
• 00613994408976: PUMP MMT-522PNAB PRDGM V2.4 BL EN LK PW
• 00613994408969: PUMP MMT-522PNAL PRDGM V2.4 CL EN LK PW
• 00613994408952: PUMP MMT-522PNAP PRDGM V2.4 PL EN LK PW
• 00613994408945: PUMP MMT-522PNAS PRDGM V2.4 SK EN LK PW
• 00613994408938: PUMP MMT-522RNAB PRDGM V2.4 BL EN LK RC
• 00613994408921: PUMP MMT-522RNAL PRDGM V2.4 CL EN LK RC
• 00613994408914: PUMP MMT-522RNAP PRDGM V2.4 PL EN LK RC