| Primary Device ID | 00840117340343 |
| NIH Device Record Key | 7918b91d-3445-4ac6-b1a7-a4894b834a74 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Resp-O2 Disposable Guedel Airway, 40 mm, Newborn, Pink |
| Version Model Number | 36315 |
| Company DUNS | 008124539 |
| Company Name | Dynarex 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840117340343 [Primary] |
| GS1 | 00840117340503 [Package] Package: Box [10 Units] In Commercial Distribution |
| GS1 | 00840117340596 [Package] Contains: 00840117340503 Package: Shipper [50 Units] In Commercial Distribution |
| CAE | Airway, Oropharyngeal, Anesthesiology |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-09 |
| Device Publish Date | 2024-11-29 |
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