MyCareLink Smart™
GUDID 00643169569744
MON 25000 MYCARELINK SMART US
MEDTRONIC, INC.
Cardiac pulse generator reader, home-use| Primary Device ID | 00643169569744 |
| NIH Device Record Key | 335e54f4-0c57-402d-88d9-34bee9571478 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MyCareLink Smart™ |
| Version Model Number | 25000 |
| 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 | 00643169569744 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P890003
FDA Product Code
| FMH | CONTAINER, SPECIMEN, STERILE |
| 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 | 2015-07-14 |
On-Brand Devices [MyCareLink Smart™]
| 00643169666320 | MON 25000 MCL SMART 2.1 US |
| 00643169569744 | MON 25000 MYCARELINK SMART US |
| 00643169527539 | MON 25000 MYCARELINK SMART US |
| 00763000305079 | MON 25000 MCL SMART 2.1 USA |
Trademark Results [MyCareLink Smart]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MYCARELINK SMART 86178859 4918670 Live/Registered |
Medtronic, Inc. 2014-01-29 |
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