| Primary Device ID | 00840117300026 |
| NIH Device Record Key | dea6573c-9646-4350-b7e2-eba5159a6302 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | My Penguin Compressor Nebulizer |
| Version Model Number | 5608PN |
| Company DUNS | 008124539 |
| Company Name | DYNAREX CORPORATION |
| Device Count | 4 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| 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 | 00616784560847 [Unit of Use] |
| GS1 | 00840117300026 [Primary] |
| 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 | 2019-12-26 |
| Device Publish Date | 2019-12-18 |
| 00840117340343 - Resp-O2 Disposable Guedel Airway, 40 mm, Newborn, Pink | 2024-12-09 |
| 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 |