| Primary Device ID | 04719871890011 |
| NIH Device Record Key | 1d748bb9-7d5e-497c-aa7f-e86b9b11fc99 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WNL |
| Version Model Number | ME6201B-FAK5000GIRED |
| Company DUNS | 658718465 |
| Company Name | FOREMOUNT ENTERPRISE 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04719871890011 [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 | 2024-07-08 |
| Device Publish Date | 2024-06-28 |
| 04719871890745 | CPR Resuscitator in Zip-Lok Bag Directions included |
| 04719871890639 | CPR Resuscitator mask in Zip-Lok Bag w/ Glove & Wipe |
| 04719871890608 | CPR Resuscitator mask in Zip-Lok Bag |
| 04719871890103 | CPR Resuscitator in big hard case with Adult+Infant Masks |
| 04719871890097 | Pocket Resuscitator in red case |
| 04719871890073 | Replacement Valve for CPR Mask |
| 04719871890059 | CPR Resuscitator in red hard case Adult/Child Infant with mask |
| 04719871890042 | CPR Mask in Red Soft Case Adult/Child Infant |
| 04719871890028 | CPR Mask in Red Soft Case Adult/Child Infant with mask |
| 04719871890011 | CPR Resuscitator in red hard case Adult/Child Infant |