| Primary Device ID | B859ERM1010 |
| NIH Device Record Key | 67b4cc64-3e03-4c5d-b864-5e7787fcc1d7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Emergency Rescue Mask |
| Version Model Number | ERM101 |
| Company DUNS | 110960383 |
| Company Name | CBX LLC |
| 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 | false |
| 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 |
|---|---|
| HIBCC | B859ERM1010 [Primary] |
| CBP | Valve, Non-Rebreathing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2020-02-15 |
| B859FRK1021 - First Responder Kit | 2021-04-09 First Responder Kit contains CPR mask, one pair of nitrile gloves, emergency shears, safety prep razor, dry cleaning towel and N |
| B859FRK10109 - First Responder Kit | 2020-03-27 First Responder Kit contains CPR Mask with oxygen port, one pair of nitrile gloves, emergency shears, safety prep razor, dry cle |
| B859ERM1010 - Emergency Rescue Mask | 2020-02-24It is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere. |
| B859ERM1010 - Emergency Rescue Mask | 2020-02-24 It is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere. |