| Primary Device ID | 00868406000068 |
| NIH Device Record Key | f1736de9-4666-438f-b02f-95ef447b5475 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AeroNOx Nitric Oxide Delivery Device |
| Version Model Number | AeroNOx |
| Catalog Number | 731-9148 |
| Company DUNS | 073179368 |
| Company Name | INTERNATIONAL BIOMEDICAL, 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 | false |
| Lot Batch | false |
| Serial Number | true |
| 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 | 5128730033 |
| sales@int-bio.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00868406000068 [Primary] |
| MRN | Apparatus, Nitric Oxide Delivery |
| 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 | 2016-09-26 |
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