| Primary Device ID | 30841716100308 |
| NIH Device Record Key | d1601cc7-177d-4675-838b-d4df224d94c2 |
| Commercial Distribution Discontinuation | 2018-05-29 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | BT2000 Automated Manifold Kit |
| Version Model Number | 014613 |
| 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 | true |
| 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 | 10841716100304 [Primary] |
| GS1 | 30841716100308 [Package] Contains: 10841716100304 Package: Shelf box [10 Units] Not in Commercial Distribution |
| GS1 | 30841716101848 [Package] Contains: 10841716100304 Package: Shelf Box [10 Units] Not in Commercial Distribution |
| DXT | Injector And Syringe, Angiographic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-04-10 |
| Device Publish Date | 2016-09-09 |
| 30841716101923 | Model BT2000 p/n 700287-023 Kit Contents: manifold with saline and contrast ports, saline tubing |
| 30841716101664 | Model BT2000 p/n 700287-019 Kit Contents: manifold with saline and contrast ports, saline tubing |
| 30841716100643 | Model BT2000 p/n 700287-021 Kit Contents: manifold with saline and contrast ports, saline tubing |
| 30841716100322 | Model BT2000 p/n 701279-004 Kit Contents: manifold with saline and contrast ports, saline tubing |
| 30841716100308 | Model BT2000 p/n 700287-017 Kit Contents: manifold with saline and contrast ports, saline tubing |
| 30841716102128 | Model BT2000 p/n 700287-026 Kit Contents: manifold with saline and contrast ports, saline tubing |
| 30841716101978 | Model BT2000 p/n 701671-001 Kit Contents: manifold with saline and contrast ports, saline tubing |
| 30841716101565 | Model BT2000 p/n 701671-002 Kit Contents: manifold with saline and contrast ports, saline tubing |
| 30841716100315 | Model BT2000 p/n 701279-002 Kit Contents: manifold with saline and contrast ports, saline tubing |
| 30841716100292 | Model BT2000 p/n 700287-016 Kit Contents: manifold with saline and contrast ports, saline tubing |
| 30841716100285 | Model BT2000 p/n 700287-013 Kit Contents: manifold with saline and contrast ports, saline tubing |
| 30841716100278 | Model BT2000 p/n 700287-012 Kit Contents: manifold with saline and contrast ports, saline tubing |