| Primary Device ID | 04719872103028 |
| NIH Device Record Key | c300f4e4-397d-4863-af93-c57e88b6d32e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bubble Humidifier |
| Version Model Number | PN-302-01 |
| Company DUNS | 658833116 |
| Company Name | ENTER MEDICAL CORPORATION |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 04719872103028 [Primary] |
| KFZ | Humidifier, Non-Direct Patient Interface (Home-Use) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-27 |
| Device Publish Date | 2023-10-19 |
| 04719872100607 - RESERVOIR | 2023-10-27 RESERVOIR |
| 04719872101208 - Seal Rite Mask | 2023-10-27 Seal Rite Mask |
| 04719872102021 - Catheter Mount | 2023-10-27 Catheter Mount |
| 04719872103028 - Bubble Humidifier | 2023-10-27Bubble Humidifier |
| 04719872103028 - Bubble Humidifier | 2023-10-27 Bubble Humidifier |
| 04719872104414 - Nasal Cannula | 2023-10-27 Nasal Cannula |
| 04719872104568 - reusable resuscitator | 2023-10-27 reusable resuscitator |
| 04719872109631 - Disposable Resuscitator | 2023-10-27 Disposable Resuscitator |
| 04719872109853 - Anaesthetic Face Mask | 2023-10-27 Anaesthetic Face Mask |