| Primary Device ID | 00813502011678 |
| NIH Device Record Key | 1cfdbff2-f96c-413f-bc18-54116a576a25 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Abiomed Impella14Fr Introducer Kit, 13cm & 25cm |
| Version Model Number | 0052-3046 |
| Company DUNS | 050636737 |
| Company Name | Abiomed, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| 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 | 00813502011678 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-05 |
| Device Publish Date | 2026-02-25 |
| 00813502011678 - Abiomed Impella14Fr Introducer Kit, 13cm & 25cm | 2026-03-05Abiomed Impella14Fr Introducer Kit, 13cm & 25cm |
| 00813502011678 - Abiomed Impella14Fr Introducer Kit, 13cm & 25cm | 2026-03-05 Abiomed Impella14Fr Introducer Kit, 13cm & 25cm |
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| 00813502012736 - Impella | 2023-11-06 ABMD Intro Kit, 14Fr x Long, Pkgd US |
| 00813502013474 - Impella | 2023-11-06 Kit, 14Fr Introducer, 13cm and 25cm |
| 00813502011388 - Impella | 2023-08-08 Impella CP C7 w V3 GWRU Set, US |
| 00813502011401 - Impella | 2023-08-08 Optical, AIC, Impella Connect, Pkgd, US |