| Primary Device ID | 20841716100004 |
| NIH Device Record Key | e2e0f12d-91ba-47eb-b1af-9177b9662fa6 |
| Commercial Distribution Discontinuation | 2019-04-10 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | ACIST Navvus® Catheter |
| Version Model Number | 014667 |
| Company DUNS | 926684994 |
| Company Name | ACIST MEDICAL SYSTEMS, 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 | 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 Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841716100007 [Primary] |
| GS1 | 20841716100004 [Package] Contains: 10841716100007 Package: Inner box [5 Units] Discontinued: 2019-04-10 Not in Commercial Distribution |
| GS1 | 30841716100650 [Package] Package: Shelf box [1 Units] Discontinued: 2019-04-10 Not in Commercial Distribution |
| GS1 | 30841716101220 [Package] Package: Shelf box [1 Units] Discontinued: 2019-04-10 Not in Commercial Distribution |
| DXO | Transducer, Pressure, Catheter Tip |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2024-06-12 |
| Device Publish Date | 2016-09-09 |
| 10841716100014 | Navvus Catheter, p/n 701481-003 |
| 20841716100004 | Navvus Catheter, p/n 701481-002 |