| Primary Device ID | 16946430423013 |
| NIH Device Record Key | 3b34ff8e-c87f-4dd5-87bd-a9a9ceb69d5a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lightning X Products, Inc |
| Version Model Number | CP641000 |
| Company DUNS | 543482946 |
| Company Name | XIAMEN COMPOWER MEDICAL TECH. CO., LTD |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06946430423016 [Primary] |
| GS1 | 16946430423013 [Package] Contains: 06946430423016 Package: carton [50 Units] In Commercial Distribution |
| 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 | 2025-06-23 |
| Device Publish Date | 2025-06-14 |
| 16946430413663 | Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital |
| 16946430423037 | Berman airway is used to establish the airway and prevent the tongue fall and the airway block. |
| 16946430423013 | It is designed to assist in providing immediate life support (mouth to mask ventilation) to heal |