| Primary Device ID | 10841470109810 |
| NIH Device Record Key | b806880f-800e-46a0-b1b8-597e7b8e4950 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aero-Pro |
| Version Model Number | 201012 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841470109813 [Primary] |
| GS1 | 10841470109810 [Package] Contains: 00841470109813 Package: [20 Units] In Commercial Distribution |
| GS1 | 20841470109817 [Package] Contains: 00841470109813 Package: [200 Units] In Commercial Distribution |
| CAH | Filter, Bacterial, Breathing-Circuit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-02 |
| Device Publish Date | 2020-08-25 |
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| 10841470105539 - BiTrac | 2025-04-21 |
| 10841470105546 - BiTrac | 2025-04-21 |
| 10841470105553 - BiTrac | 2025-04-21 |
| 10841470105560 - BiTrac | 2025-04-21 |