REVEAL® XT
GUDID 00643169494893
MONITOR 9529 REVEAL XT USA
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| Primary Device ID | 00643169494893 |
| NIH Device Record Key | 406f5912-27a5-4685-b727-35ec3007fd06 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | REVEAL® XT |
| Version Model Number | 9529 |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169494893 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K103764
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 | 2015-06-10 |
On-Brand Devices [REVEAL® XT]
| 00643169494893 | MONITOR 9529 REVEAL XT USA |
| 00643169093881 | MONITOR 9529 REVEAL XT USA SMO |
Trademark Results [REVEAL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REVEAL 98455377 not registered Live/Pending |
BLACH STOCK MUSIC TROUPE LLP 2024-03-18 |
 REVEAL 98390464 not registered Live/Pending |
Miracle Pros LLC 2024-02-04 |
 REVEAL 98388724 not registered Live/Pending |
Reaveal App, LLC 2024-02-02 |
 REVEAL 98251630 not registered Live/Pending |
Wingfoot Brands LLC 2023-11-02 |
 REVEAL 97918957 not registered Live/Pending |
Designs for Vision, Inc. 2023-05-03 |
 REVEAL 97900697 not registered Live/Pending |
C. BROWN INC. 2023-04-21 |
 REVEAL 97723468 not registered Live/Pending |
REVEAL GROUP LIMITED 2022-12-19 |
 REVEAL 97672587 not registered Live/Pending |
BESMART IP HOLDINGS LTD 2022-11-10 |
 REVEAL 97651266 not registered Live/Pending |
Duckett Fishing, LLC 2022-10-27 |
 REVEAL 97550075 not registered Live/Pending |
Reveal Data Corporation 2022-08-16 |
 REVEAL 97097883 not registered Live/Pending |
Multi-Tech Systems, Inc. 2021-10-28 |
 REVEAL 97076145 not registered Live/Pending |
Cargill, Incorporated 2021-10-15 |
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