Reveal LINQ™
GUDID 00643169845749
MON LNQ11 REVEAL LINQ USA FW2.0
MEDTRONIC, INC.
Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor| Primary Device ID | 00643169845749 |
| NIH Device Record Key | a567b7de-11c6-48e4-b826-5e43c9d1e435 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Reveal LINQ™ |
| Version Model Number | LNQ11 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169845749 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162855
FDA Product Code
| DSI | DETECTOR AND ALARM, ARRHYTHMIA |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-01-09 |
| Device Publish Date | 2017-03-10 |
On-Brand Devices [Reveal LINQ™]
| 00643169845749 | MON LNQ11 REVEAL LINQ USA FW2.0 |
| 00643169476998 | MON LNQ11 LINQ USA NEW PA |
| 00643169845893 | MON LNQ11 REVEAL LINQ USA FW2.0 |
| 00763000562632 | MON LNQ11 REVEAL LINQ USA |
| 00763000562625 | MON LNQ11 REVEAL LINQ USA |
Trademark Results [Reveal LINQ]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REVEAL LINQ 98454020 not registered Live/Pending |
Medtronic, Inc. 2024-03-18 |
 REVEAL LINQ 85481814 4689006 Live/Registered |
Medtronic, Inc. 2011-11-28 |
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