Attesta™ SR MRI SureScan™
GUDID 00763000316839
IPG ATSR01 ATTESTA SR USA
MEDTRONIC, INC.
Single-chamber implantable pacemaker, rate-responsive| Primary Device ID | 00763000316839 |
| NIH Device Record Key | 893b5afb-4a89-46e2-90af-5c2fe3b129c4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Attesta™ SR MRI SureScan™ |
| Version Model Number | ATSR01 |
| 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
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 |
| 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 |
| 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 | 00763000316839 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P980035
FDA Product Code
| LWP | Implantable pulse generator, pacemaker (non-CRT) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-07 |
| Device Publish Date | 2020-07-30 |
Devices Manufactured by MEDTRONIC, INC.
| 00199150006434 - NA | 2025-04-22 CUSTOM PACK BB11P23R4 LARGO DUAL V |
| 00199150006465 - NA | 2025-04-22 CUSTOM PACK BB12E01R8 MAINPCK |
| 00199150006618 - NA | 2025-04-22 CUSTOM PACK BB6N93R9 OSF ADPTR |
| 00199150006861 - NA | 2025-04-22 CUSTOM PACK BB6Y28R11 CMAG L I V |
| 00199150006878 - NA | 2025-04-22 CUSTOM PACK BB6Y37R3 CP PRIME |
| 20199150006896 - NA | 2025-04-22 CUSTOM PACK BB10Y97R1 5PK MANIFOLD |
| 20199150006919 - NA | 2025-04-22 CUSTOM PACK BB10Y99R1 10PK ARTERIAL Y |
| 00199150006922 - NA | 2025-04-22 CUSTOM PACK BB11Q27R2 MANIFOLD |
Trademark Results [Attesta]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ATTESTA 97673527 not registered Live/Pending |
Attesta Inc. 2022-11-11 |
 ATTESTA 97623455 not registered Live/Pending |
Attesta Labs Inc. 2022-10-07 |
 ATTESTA 97623443 not registered Live/Pending |
Attesta Labs Inc. 2022-10-07 |
 ATTESTA 88603362 not registered Live/Pending |
Medtronic, Inc. 2019-09-04 |
 ATTESTA 86885876 not registered Dead/Abandoned |
Medtronic, Inc. 2016-01-25 |
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