| Primary Device ID | 00865202000193 |
| NIH Device Record Key | 9b2719ca-eabc-44cd-8118-7414305c5757 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | The Breather Pink |
| Version Model Number | B-Pink |
| Company DUNS | 020298966 |
| Company Name | Pn Medical Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Serial Number | false |
| 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00865202000193 [Primary] |
| ION | Exerciser, Non-Measuring |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-17 |
| Device Publish Date | 2024-09-09 |
| 01240000013849 - Breather X | 2024-10-08 |
| 00850021574116 - Breather Voice | 2024-09-17 |
| 00865202000117 - Breather Recover | 2024-09-17 |
| 00865202000148 - Breather Fit | 2024-09-17 |
| 00865202000193 - The Breather Pink | 2024-09-17 |
| 00865202000193 - The Breather Pink | 2024-09-17 |
| 00865202000124 - The Breather | 2021-10-19 Inspiratory Expiratory Muscle Trainer |
| 08652020001004 - The Breather | 2021-05-26 Inspiratory Expiratory Muscle Trainer |