| Primary Device ID | M896BTI2001 |
| NIH Device Record Key | ccf80c3b-16f3-4e50-8dd8-00ef9210bd63 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Autologous Platelet Separator |
| Version Model Number | BTI200 |
| Catalog Number | BTI200 |
| Company DUNS | 809012870 |
| Company Name | ARTERIOCYTE 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M896BTI2000 [Primary] |
| HIBCC | M896BTI2001 [Package] Contains: M896BTI2000 Package: Box [1 Units] In Commercial Distribution |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2022-06-10 |
| Device Publish Date | 2016-09-09 |
| M896TRU2001 | MAGELLAN® Autologous Platelet Separator System consists of the Platelet Separator Instrument an |
| M896TRU1001 | MAGELLAN® Autologous Platelet Separator System consists of the Platelet Separator Instrument an |
| M896MAG2001 | MAGELLAN® Autologous Platelet Separator System consists of the Platelet Separator Instrument an |
| M896MAG1001 | MAGELLAN® Autologous Platelet Separator System consists of the Platelet Separator Instrument an |
| M896BTI2001 | MAGELLAN® Autologous Platelet Separator System consists of the Platelet Separator Instrument an |
| M896AMS1001 | MAGELLAN® Autologous Platelet Separator System consists of the Platelet Separator Instrument an |