| Primary Device ID | M896BTI9450 |
| NIH Device Record Key | 5d4b55cd-5986-49cd-b432-a899857e1f10 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Disposable sterile kit |
| Version Model Number | BTI945 |
| Catalog Number | BTI945 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M896BTI9450 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-04-09 |
| Device Publish Date | 2016-09-09 |
| M896BTI9800 | Sterile Disposable Kit containing single-patient-use components necessary for each platelet sepa |
| M896BTI9450 | Sterile Disposable Kit containing single-patient-use components necessary for each platelet sepa |