| 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 |
| 00810169720004 - Indigo System | 2024-10-16 CAT12 100 XTORQ plus Lightning Bolt Aspiration Tubing, no CE |
| 00810169720011 - Indigo System | 2024-10-16 CAT12 100 HTORQ plus Lightning Bolt Aspiration Tubing, no CE |
| 00810169720028 - Indigo System | 2024-10-16 CAT12 115 XTORQ plus Lightning Bolt Aspiration Tubing, no CE |
| 00810169720035 - Indigo System | 2024-10-16 CAT12 115 HTORQ plus Lightning Bolt Aspiration Tubing, no CE |
| 00810169721179 - Indigo System | 2024-10-16 CAT6X + Lightning Bolt |
| 00810169721186 - Indigo System | 2024-10-16 CAT6X w/Sonic + Lightning Bolt |
| M242RBYPODJ150 - POD | 2024-08-23 RBYPODJ15 GS1-00814548016702 |
| 00815948024267 - Indigo System | 2024-07-26 CAT16 HTORQ 115cm, Select + 135cm BER Tip, Lightning Flash 2.0 Tubing |