| Primary Device ID | 00850015884191 |
| NIH Device Record Key | 9d4624ab-02ae-4396-a0b1-c824aa51978d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Synchronis |
| Version Model Number | 2161-40000 |
| Catalog Number | 2161-40000 |
| Company DUNS | 080160207 |
| Company Name | SYNCHRONIS MEDICAL, 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 | 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850015884191 [Primary] |
| GS1 | 00850015884214 [Package] Package: Case [25 Units] In Commercial Distribution |
| KDQ | Bottle, Collection, Vacuum |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-16 |
| Device Publish Date | 2020-09-08 |
| 00850015884238 | Chest Tube Valve Nonsterile |
| 00850015884191 | Chest Tube Valve Sterile |