| Primary Device ID | 00840117313064 |
| NIH Device Record Key | 4844e692-ae32-47a0-9147-492c4eb8cb58 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Resp-O2 Endotracheal Tube Cuffed, 8.0 mm |
| Version Model Number | 36242 |
| Company DUNS | 008124539 |
| Company Name | Dynarex Corporation |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 00840117313064 [Package] Contains: 00840117317536 Package: Box [10 Units] In Commercial Distribution |
| GS1 | 00840117313071 [Package] Package: Shipper [10 Units] In Commercial Distribution |
| GS1 | 00840117317536 [Primary] |
| BTR | Tube, Tracheal (W/Wo Connector) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-01 |
| Device Publish Date | 2024-10-24 |
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| 00840117340510 - Resp-O2 Disposable Guedel Airway, 50 mm, Infant, Blue | 2024-12-09 |
| 00840117340527 - Resp-O2 Disposable Guedel Airway,60 mm, Toddler, Black | 2024-12-09 |
| 00840117340374 - Resp-O2 Disposable Guedel Airway, 70 mm, Child, White | 2024-12-09 |
| 00840117340381 - Resp-O2 Disposable Guedel Airway, 80 mm, Adult Small, Green | 2024-12-09 |
| 00840117338128 - Sharps Clean-Up Kit | 2024-11-26 Contents: Sharps Shaft, Pair of Gloves, Tweezers, BZK Towelette, Biohazard Bag, Twist Tie. |
| 00810180840163 - DynaSafety Cotton-Tipped Applicators in Sealed Vial,3" | 2024-11-19 |
| 00840117341210 - Medicine Cups 1oz | 2024-11-05 |