| Primary Device ID | 07045432001921 |
| NIH Device Record Key | 63f1497e-e515-4782-90a1-8531bdf90e18 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeoNatalie Complete Dark (US) |
| Version Model Number | 104-10003 |
| Catalog Number | 104-10003 |
| Company DUNS | 730624095 |
| Company Name | Laerdal Medical AS |
| 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 | false |
| 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 |
| Phone | (877) 523-7325 |
| cutomerservice@laerdal.com |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 50 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07045432001921 [Primary] |
| BTM | Ventilator, Emergency, Manual (Resuscitator) |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07045432001921]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-09 |
| 07045432091151 | The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and |
| 07045432001921 | The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and |