Paradigm® REAL-Time Revel™

GUDID 00643169513075

PUMP MMT-523RNAL PRDGM 3.0 CL EN RC

MEDTRONIC MINIMED, INC.

Ambulatory insulin infusion pump, electronic

• Primary Device ID: 00643169513075
• NIH Device Record Key: 716b0ffb-d583-4cd2-a8b8-db8b60f49df3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paradigm® REAL-Time Revel™
• Version Model Number: MMT-523RNAL
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169513075 [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: 2014-09-23

On-Brand Devices [Paradigm® REAL-Time Revel™]

• 00613994920799: PUMP MMT-523KNS PRDGM INS V2.4 SK EN
• 00613994920782: PUMP MMT-523KNP PRDGM INS V2.4 PL EN
• 00613994920775: PUMP MMT-523KNL PRDGM INS V2.4 CL EN
• 00613994920768: PUMP MMT-523KNH PRDGM INS V2.4 PK EN
• 00613994920751: PUMP MMT-523KNB PRDGM INS V2.4 BL EN
• 00613994920744: PUMP MMT-523KLNS PRDGM INS V2.4 SK EN LN
• 00613994920737: PUMP MMT-523KLNP PRDGM INS V2.4 PL EN LN
• 00613994920720: PUMP MMT-523KLNL PRDGM INS V2.4 CL EN LN
• 00613994920713: PUMP MMT-523KLNH PRDGM INS V2.4 PK EN LN
• 00613994920706: PUMP MMT-523KLNB PRDGM INS V2.4 BL EN LN
• 00613994920669: PUMP MMT-723KNS PRDGM INS V2.4 SK EN
• 00613994920652: PUMP MMT-723KNP PRDGM INS V2.4 PL EN
• 00613994920645: PUMP MMT-723KNL PRDGM INS V2.4 CL EN
• 00613994920638: PUMP MMT-723KNH PRDGM INS V2.4 PK EN
• 00613994920621: PUMP MMT-723KNB PRDGM INS V2.4 BL EN
• 00613994920614: PUMP MMT-723KLNS PRDGM INS V2.4 SK EN LN
• 00613994920607: PUMP MMT-723KLNP PRDGM INS V2.4 PL EN LN
• 00613994920591: PUMP MMT-723KLNL PRDGM INS V2.4 CL EN LN
• 00613994920584: PUMP MMT-723KLNH PRDGM INS V2.4 PK EN LN
• 00613994920577: PUMP MMT-723KLNB PRDGM INS V2.4 BL EN LN
• 00613994919137: PUMP MMT-523NAS PRDGM INS V2.4 SK EN
• 00613994919120: PUMP MMT-523NAP PRDGM INS V2.4 PL EN
• 00613994919113: PUMP MMT-523NAL PRDGM INS V2.4 CL EN
• 00613994919106: PUMP MMT-523NAH PRDGM INS V2.4 PK EN
• 00613994919090: PUMP MMT-523NAB PRDGM INS V2.4 BL EN
• 00613994918758: PUMP MMT-523LNAB PRDGM INS V2.4 BL EN LN
• 00613994918741: PUMP MMT-523LNAH PRDGM INS V2.4 PK EN LN
• 00613994918734: PUMP MMT-523LNAL PRDGM INS V2.4 CL EN LN
• 00613994918727: PUMP MMT-523LNAP PRDGM INS V2.4 PL EN LN
• 00613994918710: PUMP MMT-523LNAS PRDGM INS V2.4 SK EN LN
• 00613994918703: PUMP MMT-523PNAB PRDGM INS V2.4 BL EN PW
• 00613994918697: PUMP MMT-523PNAH PRDGM INS V2.4 PK EN PW
• 00613994918680: PUMP MMT-523PNAL PRDGM INS V2.4 CL EN PW
• 00613994918673: PUMP MMT-523PNAP PRDGM INS V2.4 PL EN PW
• 00613994918666: PUMP MMT-523PNAS PRDGM INS V2.4 SK EN PW
• 00613994918659: PUMP MMT-523RNAB PRDGM INS V2.4 BL EN RC
• 00613994918642: PUMP MMT-523RNAH PRDGM INS V2.4 PK EN RC
• 00613994918635: PUMP MMT-523RNAL PRDGM INS V2.4 CL EN RC
• 00613994918628: PUMP MMT-523RNAP PRDGM INS V2.4 PL EN RC
• 00613994918611: PUMP MMT-523RNAS PRDGM INS V2.4 SK EN RC
• 00613994904522: PUMP MMT-723LNAB PRDGM INS V2.4 BL EN LN
• 00613994904515: PUMP MMT-723LNAH PRDGM INS V2.4 PK EN LN
• 00613994904508: PUMP MMT-723LNAL PRDGM INS V2.4 CL EN LN
• 00613994904492: PUMP MMT-723LNAP PRDGM INS V2.4 PL EN LN
• 00613994904485: PUMP MMT-723LNAS PRDGM INS V2.4 SK EN LN
• 00613994904478: PUMP MMT-723PNAB PRDGM INS V2.4 BL EN PW
• 00613994904461: PUMP MMT-723PNAH PRDGM INS V2.4 PK EN PW
• 00613994904454: PUMP MMT-723PNAL PRDGM INS V2.4 CL EN PW
• 00613994904447: PUMP MMT-723PNAP PRDGM INS V2.4 PL EN PW
• 00613994904430: PUMP MMT-723PNAS PRDGM INS V2.4 SK EN PW