| Primary Device ID | M68920510060 |
| NIH Device Record Key | e6c644af-a271-4c20-9ffe-a9e59b2c8fe1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sentinel Chest Trauma Kit |
| Version Model Number | 06 |
| Catalog Number | 20-510 |
| Company DUNS | 118492643 |
| Company Name | Safeguard US Operating, 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M68920510060 [Primary] |
| GAA | Needle, Aspiration And Injection, Disposable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-06 |
| Device Publish Date | 2022-11-28 |
| M68920510030 | SENTINEL CHEST TRAUMA KIT 2 ea Sentinel Dual vent Chest seals with Sentinel 10x extreme strength |
| M68920510050 | SENTINEL CHEST TRAUMA KIT 2 ea - Sentinel Dual vent Chest seals with Sentinel 10x extreme streng |
| M68920510060 | SENTINEL CHEST TRAUMA KIT 2 ea - Sentinel Dual vent Chest seals with Sentinel 10x extreme streng |
| M68920510070 | SENTINEL CHEST TRAUMA KIT 2 ea - Sentinel Dual vent Chest seals with Sentinel 10x extreme streng |