| 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 |