| Primary Device ID | M896MAR01JPN1050 |
| NIH Device Record Key | edd54316-11fa-46d0-a9b6-78b1087a0807 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MAGELLAN Surgical Tools for Erythrocyte & Marrow Preparation Kit |
| Version Model Number | MAR01-JPN-105 |
| Company DUNS | 809012870 |
| Company Name | ARTERIOCYTE MEDICAL SYSTEMS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 508-435-7412 |
| customerservice@arteriocyte.com | |
| Phone | 508-435-7412 |
| customerservice@arteriocyte.com | |
| Phone | 508-435-7412 |
| customerservice@arteriocyte.com | |
| Phone | 508-435-7412 |
| customerservice@arteriocyte.com | |
| Phone | 508-435-7412 |
| customerservice@arteriocyte.com | |
| Phone | 508-435-7412 |
| customerservice@arteriocyte.com | |
| Phone | 508-435-7412 |
| customerservice@arteriocyte.com | |
| Phone | 508-435-7412 |
| customerservice@arteriocyte.com | |
| Phone | 508-435-7412 |
| customerservice@arteriocyte.com | |
| Phone | 508-435-7412 |
| customerservice@arteriocyte.com | |
| Phone | 508-435-7412 |
| customerservice@arteriocyte.com | |
| Phone | 508-435-7412 |
| customerservice@arteriocyte.com | |
| Phone | 508-435-7412 |
| customerservice@arteriocyte.com | |
| Phone | 508-435-7412 |
| customerservice@arteriocyte.com | |
| Phone | 508-435-7412 |
| customerservice@arteriocyte.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M896MAR01JPN1050 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-12-17 |
| Device Publish Date | 2019-12-09 |
| M896MAR01ATS0 | Sterile Disposable Kit Containing single patient-use components necessary for each platelet sepa |
| M896MAR01JPN450 | MAR01-JPN-45 |
| M896MAR01JPN250 | MAR01-JPN-25 |
| M896MAR01JPN1050 | MAR01-JPN-105 |
| M896MAR01JPN800 | MAR01-JPN-80 |