| Primary Device ID | 00802526580208 |
| NIH Device Record Key | dbc870d8-0bbe-4a29-8c19-cc32cf652e6a |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 6763 |
| Company DUNS | 106295384 |
| Company Name | BOSTON SCIENTIFIC CORPORATION |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00802526580208 [Primary] |
| DTC | ANALYZER, PACEMAKER GENERATOR FUNCTION |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00802526580208]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00802526580208]
Moist Heat or Steam Sterilization;Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-11-16 |
| 08714729035404 - NA | 2024-06-06 Arterial Entry Needle |
| 08714729035411 - NA | 2024-06-06 Arterial Entry Needle |
| 08714729841692 - Rhythmia™ Mapping System | 2024-06-06 ECG Cable - Trunk - US AAMI |
| 08714729841715 - Rhythmia™ Mapping System | 2024-06-06 ECG Cable - Limbs - US AAMI |
| 08714729841739 - Rhythmia™ Mapping System | 2024-06-06 ECG Cable - Chest - US AAMI |
| 08714729938507 - RHYTHMIA HDx™ | 2024-06-06 ECG IN Cable (Trunk) |
| 08714729938514 - RHYTHMIA HDx™ | 2024-06-06 ECG IN Cable (Trunk) |
| 08714729938521 - RHYTHMIA HDx™ | 2024-06-06 ECG IN Cable (Limb and Chest) |