| Primary Device ID | 10841470111035 |
| NIH Device Record Key | a4426c43-7bc7-43df-87ad-313904319e6d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | O2-CPAP Valve |
| Version Model Number | 313-7717 |
| Company DUNS | 030619483 |
| Company Name | PULMODYNE INC |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841470111038 [Primary] |
| GS1 | 10841470111035 [Package] Contains: 00841470111038 Package: [10 Units] In Commercial Distribution |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-11 |
| Device Publish Date | 2020-12-03 |
| 10841470100145 - O2-MAX | 2025-04-21 |
| 10841470105508 - BiTrac | 2025-04-21 |
| 10841470105515 - BiTrac | 2025-04-21 |
| 10841470105522 - BiTrac | 2025-04-21 |
| 10841470105539 - BiTrac | 2025-04-21 |
| 10841470105546 - BiTrac | 2025-04-21 |
| 10841470105553 - BiTrac | 2025-04-21 |
| 10841470105560 - BiTrac | 2025-04-21 |