| Primary Device ID | 10073796011038 |
| NIH Device Record Key | 37893b80-1809-41c6-b7a6-ec5a6ede4e95 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Medication Container |
| Version Model Number | U100-3 |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | true |
| Phone | 1-800-634-4350 |
| ohiquality@omron.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00073796011031 [Primary] |
| GS1 | 10073796011038 [Package] Contains: 00073796011031 Package: Case [200 Units] In Commercial Distribution |
| CAF | Nebulizer (Direct Patient Interface) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-12-03 |
| Device Publish Date | 2018-10-31 |
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