| 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 |
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| 08714729042594 - Passport Kit | 2024-04-05 Balloon Dilatation Catheter Kit |
| 08714729042600 - Passport Kit | 2024-04-05 Balloon Dilatation Catheter Kit |
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| 08714729191872 - Passport | 2024-04-05 Balloon Dilatation Catheter |