MyCareLink™

GUDID 00763000113797

MON 24952B MYCARELINK/SVC USA

MEDTRONIC, INC.

Cardiac pulse generator reader, home-use

• Primary Device ID: 00763000113797
• NIH Device Record Key: c05851a0-ef6f-4da6-be0b-afd57aa33cdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyCareLink™
• Version Model Number: 24952B
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000113797 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-17
• Device Publish Date: 2018-06-16

On-Brand Devices [MyCareLink™]

• 00643169947115: MON 24950JLQ MYCARELINK/SVC USA LINQ
• 00643169725386: MON 24950KLQ MYCARELINK/SVC USA LINQ
• 00643169725379: MON 24950KLQ MYCARELINK/SVC USA LINQ
• 00643169725362: MON 24950KLQ MYCARELINK/SVC USA LINQ
• 00643169725195: MON 24950K MYCARELINK/SVC USA
• 00643169705753: MON 24950JLQ MYCARELINK/SVC LINQ MS2131
• 00643169705746: MON 24950J MYCARELINK/SVC US MS2131
• 00643169658134: MON 24950JLQ MYCARELINK/SVC USA LINQ
• 00643169658127: MON 24950JLQ MYCARELINK/SVC USA LINQ
• 00643169657885: MON 24950J MYCARELINK/SVC USA
• 00643169552289: MON 24950GLQ MYCARELINK/SVC USA LINQ BT
• 00643169552104: MON 24950G MYCARELINK/SVC USA
• 00643169486744: MON 24950D1 MYCARELINK/SVC MKT USA
• 00643169469891: MONITOR 24955 FRU USA 2BD
• 00643169469884: MONITOR 24955 FRU US CAN ANZ EUR 1 BD
• 00643169452060: MON 24950E MYCARELINK/SVC USA
• 00643169441101: MON 24950D MYCARELINK US M2.0
• 00643169367203: MON 24950D MYCARELINK/SVC USA
• 00763000114015: MON 24950LLQ MYCARELINK/SVC LINQ USA
• 00763000114008: MON 24950LLQ MYCARELINK/SVC LINQ USA
• 00763000113995: MON 24950LLQ MYCARELINK/SVC LINQ USA
• 00763000113797: MON 24952B MYCARELINK/SVC USA
• 00763000014384: MON 24952A MYCARELINK/SVC USA
• 00763000113988: MON 24952B MYCARELINK/SVC USA
• 00763000033217: MON 24950L USA MKT M10.2
• 00763000033194: MON 24950L USA MKT M10.2 USA
• 00643169552043: MON 24950L USA MKT M10.2 USA
• 00763000304966: MON 24950LZ MYCARELINK USA MKT MCL
• 00763000304959: MON 24950LZ MYCARELINK USA MKT MCLX
• 00763000304942: MON 24950LZ MYCARELINK USA MKT MCL
• 00643169552272: MON 24950L USA MKT M10.2 USA MKT
• 00763000367824: MON 24950M MYCARELINK/SVC USA
• 00763000367893: MONITOR 24955 FRU USA GOLD
• 00763000367886: MONITOR 24955 FRU USA GOLD
• 00763000414047: MON 24950M USA MKT M13 CORE
• 00763000414030: MON 24950M USA MKT M13 CORE
• 00763000414023: MON 24950M USA MKT M13 CORE
• 00763000586232: MON 24952C MYCARELINK USA M13 - REFURB
• 00763000586225: MON 24952C MYCARELINK USA M13
• 00763000612665: MON 24950M USA MKT 13 CORE REFURB MCL
• 00763000612658: MON 24950M USA MKT 13 CORE REFURB MCLX