| Primary Device ID | M896IFLXMAX020 |
| NIH Device Record Key | 5daaa5a3-543b-49d8-a7e3-c274e862e1ae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Magellan Influx |
| Version Model Number | IFLX-MAX-02 |
| 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 | true |
| 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 | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M896IFLXMAX020 [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 | 2023-06-14 |
| Device Publish Date | 2023-06-06 |
| M896IFLXMAX020 - Magellan Influx | 2023-06-14MAR0 Kit with 2.5cc Influx Max |
| 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 |