| Primary Device ID | 00855168008074 |
| NIH Device Record Key | 64fedc70-2f8f-4011-b4ca-25cfb8ee9ef6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CBCII ConstaVac |
| Version Model Number | 225-029-000 |
| Catalog Number | 225-029-000 |
| 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 |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855168008074 [Primary] |
| GS1 | 00855168008081 [Package] 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 | 2018-11-22 |
| Device Publish Date | 2018-10-22 |
| 00855168008388 | CBCII Constavac Blood Conservation System (No Drain) |
| 00855168008258 | CBCII with Quick Disconnect, 1/8” Round PVC Drain & Trocar |
| 00855168008074 | CBCII Collection Only Kit with 1/8” Round PVC Wound Drain |
| 00855168008029 | CBCII Conservation Kit with 1/8” Round PVC Wound Drain |