| Primary Device ID | 00861122000336 |
| NIH Device Record Key | 9028beb5-b581-4da2-aead-f1e167720f57 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProGen Phlebotomy Kit |
| Version Model Number | BELL-82500-A |
| Catalog Number | BELL-82500-A |
| Company DUNS | 080357711 |
| Company Name | CELLMEDIX HOLDINGS, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00861122000336 [Primary] |
| GS1 | 10861122000333 [Package] Package: Shipper [100 Units] In Commercial Distribution |
| OFM | Phlebotomy Blood Collection Kit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-06-15 |
| 10861122000302 - Centripid PC | 2019-04-09 The Centrepid PC design concept is predicated on providing an easy to use device for platelet rich plasma (PRP) that demonstrate |
| 00861122000312 - ProGen PC Kit | 2019-04-09 The ProGen PC design concept is predicated on providing an easy to use device for platelet rich plasma (PRP) that demonstrates h |
| 10861122000326 - Phlebotomy Kit | 2018-03-29 |
| 00861122000336 - ProGen Phlebotomy Kit | 2018-03-29 |
| 00861122000336 - ProGen Phlebotomy Kit | 2018-03-29 |