| Primary Device ID | 00814548019703 |
| NIH Device Record Key | a7b5c151-4b0d-4916-b76c-8b8c2d109845 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Indigo Aspiration System |
| Version Model Number | IAPS3-A |
| Company DUNS | 191077671 |
| Company Name | PENUMBRA, INC. |
| 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 | true |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814548019703 [Primary] |
| DXE | Catheter, Embolectomy |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-08 |
| Device Publish Date | 2018-10-08 |
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| 00810169722091 - swiftMATCH Coil, Extra Soft | 2026-02-03 swiftMATCH Coil, Extra Soft, 2mm x 6cm |
| 00810169722107 - swiftMATCH Coil, Extra Soft | 2026-02-03 swiftMATCH Coil, Extra Soft, 3mm x 4cm |