| Primary Device ID | B283ELXB0 |
| NIH Device Record Key | b00128bc-63fb-41e8-8646-9d1a12812e32 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EMPACT Active Shooter Tool Kit- Advanced Bleeding |
| Version Model Number | B283ELXB0 |
| Company DUNS | 827067880 |
| Company Name | Pro1tek |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 2622328790 |
| info@buypro1tek.com | |
| Phone | 2622328790 |
| info@buypro1tek.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B283ELXB0 [Primary] |
| OVR | Kit, First Aid, Talking |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-26 |
| Device Publish Date | 2018-09-25 |
| B283ELXB0 | EMPACT is an Emergency Medical Passive Active Shooter Countermeasure Tool Kit. Medical Trauma F |
| B283E6HCXPG0 | EMPACT is an Emergency Medical Passive Active Shooter Countermeasure Tool Kit. Medical Trauma Fi |
| B283E6HCXPE0 | EMPACT is an Emergency Medical Passive Active Shooter Countermeasure Tool Kit. Medical Trauma Fi |