| Primary Device ID | M896TRU300JPN1 |
| NIH Device Record Key | fe276041-d28f-4c80-bd9b-c653c2933c9f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Magellan Complete Disposable Kit |
| Version Model Number | TRU300-JPN |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M896TRU300JPN0 [Primary] |
| HIBCC | M896TRU300JPN1 [Package] Contains: M896TRU300JPN0 Package: Box [5 Units] In Commercial Distribution |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-07-23 |
| Device Publish Date | 2019-06-13 |
| M896MDK300JPN0 | MDK300-JPN |
| M896TRU300JPN1 | TRU300-JPN |