| Primary Device ID | 00073796801458 |
| NIH Device Record Key | dcb1a143-ce34-4ea7-8830-b18efee5a497 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Omron Nebulizer Kit with Air Tube and Mouthpiece |
| Version Model Number | C801NEB |
| Catalog Number | C801NEB |
| Company DUNS | 054318779 |
| Company Name | Omron Healthcare, Inc. |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-634-4350 |
| ohiquality@omron.com |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00073796801458 [Primary] |
| GS1 | 10073796801455 [Package] Package: Case [50 Units] In Commercial Distribution |
| CAF | Nebulizer (Direct Patient Interface) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-05-17 |
| 00073796801458 | Nebulizer Kit with Air Tube and Mouthpiece for NE-C801 |
| 00073796390006 | Nebulizer Kit with Air Tube and Mouthpiece |