| Primary Device ID | 00855168008180 |
| NIH Device Record Key | 48489052-7a46-40f7-a289-057bea8bcc89 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Constavac CBCII |
| Version Model Number | 225-028-614 |
| Catalog Number | 225-028-614 |
| Company DUNS | 112462671 |
| Company Name | 3T 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 | 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 | true |
| OTC Over-The-Counter | false |
| Phone | 7345259580 |
| sales@3tmedical.com |
| Device Size Text, specify | 0 |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855168008173 [Primary] |
| GS1 | 00855168008180 [Package] Contains: 00855168008173 Package: Pack [6 Units] In Commercial Distribution |
| CAC | Apparatus, Autotransfusion |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-11 |
| Device Publish Date | 2019-02-28 |
| 00855168008289 | CBCII with Quick Disconnect, 1/4” Round PVC Drain & Trocar |
| 00855168008180 | CBCII Blood Conservation Kit with 1/8” Round PVC Drain & Double Trocar |