| Primary Device ID | 08714729454533 |
| NIH Device Record Key | 86e9db02-2988-41cb-9f99-3428074ec0cb |
| Commercial Distribution Discontinuation | 2020-12-16 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Model 2104 Tubing Kit |
| Version Model Number | M0043521040 |
| Catalog Number | M0043521040 |
| Company DUNS | 021717889 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08714729454533 [Primary] |
| LPB | Cardiac ablation percutaneous catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-07-11 |
| Device Publish Date | 2014-09-24 |
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| 08714729808503 - Flextome® Cutting Balloon® | 2025-12-12 Microsurgical Dilatation Device |
| 08714729808510 - Flextome® Cutting Balloon® | 2025-12-12 Microsurgical Dilatation Device |
| 08714729808527 - Flextome® Cutting Balloon® | 2025-12-12 Microsurgical Dilatation Device |
| 08714729808534 - Flextome® Cutting Balloon® | 2025-12-12 Microsurgical Dilatation Device |
| 08714729808541 - Flextome® Cutting Balloon® | 2025-12-12 Microsurgical Dilatation Device |