Medtronic CareLink® Programmer

GUDID 00613994175397

PROG 2090 TEL C US EN UPGRADE SW JUN06

MEDTRONIC, INC.

Pacemaker programmer

• Primary Device ID: 00613994175397
• NIH Device Record Key: 614fa889-1da8-414e-b49b-184f501565f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medtronic CareLink® Programmer
• Version Model Number: 2090
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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 -7.6 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -7.6 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -7.6 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -7.6 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -7.6 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -7.6 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -7.6 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -7.6 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -7.6 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -7.6 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -7.6 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -7.6 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -7.6 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -7.6 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -7.6 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -7.6 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -7.6 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -7.6 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994175397 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P890003

FDA Product Code

• OSR: Pacemaker/icd/crt non-implanted components

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: 2014-09-23

On-Brand Devices [Medtronic CareLink® Programmer]

• 00613994581594: PRGM 2090 USA EN OS MIGRATION UPGRADE
• 00613994581570: PRGM 2090 USA EN OS MIGRATION EXTENSION
• 00613994434937: PROG 2090 TELC USA MKT EN EXT
• 00613994175403: PROG 2090 TEL C US EN SW JUN06
• 00613994175397: PROG 2090 TEL C US EN UPGRADE SW JUN06
• 00613994127631: PROGRAMMER 2090W Tel C UPGRADE US
• 00721902824692: PRGM 2090AA4 PORTABLECRM
• 00885074301440: PROGRAMMER 2090W TELEMETRY C US