| Primary Device ID | 00840117308794 |
| NIH Device Record Key | 2687a339-26e6-404e-bde4-837682b59fcc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dynarex My Resp-O2 Penguin Compressor Nebulizer |
| Version Model Number | 34405 |
| 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 | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840117308794 [Primary] |
| GS1 | 00840117308800 [Package] Package: Case [4 Units] In Commercial Distribution |
| 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 | 2021-01-27 |
| Device Publish Date | 2021-01-19 |
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| 00840117343689 - Durma+ DynaGinate AG, Calcium Alginate Dressing, 4" x 4" | 2025-06-06 |
| 00840117344594 - Durma+ Island Dressing, 6" x 3 1/8" | 2025-06-06 Sterile-EO |
| 00840117344624 - Durma+ Island Dressing, 4" x 13 3/4" | 2025-06-06 |
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| 00840117345829 - Durma+ Petrolatum Gauze Dressing, 1" x 8", Neutral Wound, Dressing | 2025-06-06 3% Bismuth Tribromophenate in a Petrolatum Blend, Sterile-R |