MyCareLink™
GUDID 00643169657885
MON 24950J MYCARELINK/SVC USA
MEDTRONIC, INC.
Cardiac pulse generator reader, home-use| Primary Device ID | 00643169657885 |
| NIH Device Record Key | 6e6f10ca-0478-41a6-8bd2-e78bf4adcd2b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MyCareLink™ |
| Version Model Number | 24950J |
| 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 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169657885 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P890003
FDA Product Code
| NVZ | Pulse generator, permanent, implantable |
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 | 2015-12-18 |
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 |
Trademark Results [MyCareLink]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MYCARELINK 85717325 4585059 Live/Registered |
Medtronic, Inc. 2012-08-30 |
 MYCARELINK 85656367 4800020 Live/Registered |
Medtronic, Inc. 2012-06-20 |
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