| Primary Device ID | M896RO3001 |
| NIH Device Record Key | b80dc664-e770-4fac-842c-d1fd388b2730 |
| Commercial Distribution Discontinuation | 2019-11-04 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Magellan® Complete Disposable kit |
| Version Model Number | RO-300 |
| Catalog Number | RO-300 |
| Company DUNS | 809012870 |
| Company Name | ARTERIOCYTE MEDICAL SYSTEMS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 866-660-2674 |
| customerservice@arteriocyte.com | |
| Phone | 866-660-2674 |
| customerservice@arteriocyte.com | |
| Phone | 866-660-2674 |
| customerservice@arteriocyte.com | |
| Phone | 866-660-2674 |
| customerservice@arteriocyte.com | |
| Phone | 866-660-2674 |
| customerservice@arteriocyte.com | |
| Phone | 866-660-2674 |
| customerservice@arteriocyte.com | |
| Phone | 866-660-2674 |
| customerservice@arteriocyte.com | |
| Phone | 866-660-2674 |
| customerservice@arteriocyte.com | |
| Phone | 866-660-2674 |
| customerservice@arteriocyte.com | |
| Phone | 866-660-2674 |
| customerservice@arteriocyte.com | |
| Phone | 866-660-2674 |
| customerservice@arteriocyte.com | |
| Phone | 866-660-2674 |
| customerservice@arteriocyte.com | |
| Phone | 866-660-2674 |
| customerservice@arteriocyte.com | |
| Phone | 866-660-2674 |
| customerservice@arteriocyte.com | |
| Phone | 866-660-2674 |
| customerservice@arteriocyte.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M896RO3000 [Primary] |
| HIBCC | M896RO3001 [Package] Contains: M896RO3000 Package: [5 Units] Discontinued: 2019-11-04 Not in Commercial Distribution |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-11-05 |
| Device Publish Date | 2017-11-06 |
| M896IFLXMAX020 - Magellan Influx | 2023-06-14 MAR0 Kit with 2.5cc Influx Max |
| M896AMS500220500 - Precise | 2023-06-07 Precise Separation Canister, 60 mL |
| M896AMS500220530 - Precise | 2023-06-07 Precise Separation Canister, 60mL |
| M896AMS500220560 - Precise | 2023-06-07 Precise Separation Canister, 60 mL |
| M896AMS500350500 - Precise | 2023-06-07 Precise Separation Canister, 120 mL |
| M896AMS500350530 - Precise | 2023-06-07 Precise Separation Canister, 120 mL |
| M896AMS500350560 - Precise | 2023-06-07 Precise Separation Canister, 120 mL |
| M896PRCDIA0600 - Precise Diamond | 2023-06-07 Precise Diamond - 60 mL LP Kit |