| Primary Device ID | 00840117313361 |
| NIH Device Record Key | b1db6776-4e3b-466c-bb1b-a9643555d5c5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Resp-O2 Endotracheal Tube Introducer (Bougie), Adult, 15 FR |
| Version Model Number | 36261 |
| Company DUNS | 008124539 |
| Company Name | DYNAREX CORPORATION |
| Device Count | 10 |
| 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 | false |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840117313361 [Primary] |
| GS1 | 00840117313378 [Package] Package: Master Shipper [20 Units] In Commercial Distribution |
| GS1 | 00840117322981 [Unit of Use] |
| KBI | Bougie, Eustachian |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-24 |
| Device Publish Date | 2022-05-16 |
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| 00810180842235 - DispoSafety Biohazard Bags, 40" x 46", 2 MIL, 45 Gallon | 2025-06-24 |
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