| Primary Device ID | M791MH21500 |
| NIH Device Record Key | 5717da18-1e28-41f1-b12d-2ea4e8814c63 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioAccess Marrow Collection System |
| Version Model Number | MH2150 |
| Company DUNS | 942203001 |
| Company Name | BIOACCESS 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 | false |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M791MH21500 [Primary] |
| LWE | Bone Marrow Collection/Transfusion Kit |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-11 |
| Device Publish Date | 2022-08-03 |
| M791NGD10000 - Next Gen Driver | 2022-08-12 |
| M791NGD1005A0 - Next Gen Driver | 2022-08-12 |
| M791SBT10000 - Small Bone Tool | 2022-08-12 |
| M791SBT1000HT0 - Small Bone Tool | 2022-08-12 |
| M791SBT10010 - Small Bone Tool | 2022-08-12 |
| M791SBT1001A0 - Small Bone Tool | 2022-08-12 |
| M791SBT10040 - Small Bone Tool | 2022-08-12 |
| M791SBT10050 - Small Bone Tool | 2022-08-12 |