Product code BYW
- Device name
- Device, Rebreathing
- Medical specialty
- Anesthesiology
- Device class
- 1
- Regulation number
- 868.5675
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 14250105630524 | Paediatric Mask; Newborn | VBM Medizintechnik GmbH | 2025-04-25 |
| 14250105630531 | Paediatric Mask; Infant | VBM Medizintechnik GmbH | 2025-04-25 |
| 14250105630548 | Paediatric Mask; Child | VBM Medizintechnik GmbH | 2025-04-25 |
| 24250105630545 | Paediatric Mask; Child | VBM Medizintechnik GmbH | 2025-04-25 |
| 24250105630538 | Paediatric Mask; Infant | VBM Medizintechnik GmbH | 2025-04-25 |
| 24250105630521 | Paediatric Mask; Newborn | VBM Medizintechnik GmbH | 2025-04-25 |
| 06975029700078 | MTEHFYAF | Beijing Xingjian Yongzhen Technology Co. , Ltd. | 2024-06-12 |
| 06975029700061 | MTEHFYAF | Beijing Xingjian Yongzhen Technology Co. , Ltd. | 2024-06-12 |
| 06975029700054 | MTEHFYAF | Beijing Xingjian Yongzhen Technology Co. , Ltd. | 2024-06-12 |
| 00840155400009 | MedSource Rebreather Mask | MEDSOURCE INTERNATIONAL LLC | 2021-05-27 |
| 00840155400016 | MedSource Rebreather Mask | MEDSOURCE INTERNATIONAL LLC | 2021-05-27 |
| 00840155400047 | MedSource Rebreather Mask | MEDSOURCE INTERNATIONAL LLC | 2021-05-27 |
| 00840155400054 | MedSource Rebreather Mask | MEDSOURCE INTERNATIONAL LLC | 2021-05-27 |
| 14250105628514 | n.a. | VBM Medizintechnik GmbH | 2020-08-25 |
| 24250105628504 | n.a. | VBM Medizintechnik GmbH | 2020-08-25 |
| 24250105628511 | n.a. | VBM Medizintechnik GmbH | 2020-08-25 |
| 24250105628528 | n.a. | VBM Medizintechnik GmbH | 2020-08-25 |
| 14250105628521 | n.a. | VBM Medizintechnik GmbH | 2020-08-25 |
| 14250105628507 | n.a. | VBM Medizintechnik GmbH | 2020-08-25 |
| 00604351600515 | Monaghan Medical Corporation | Monaghan Medical Corporation | 2020-07-30 |
| 50604351600510 | Monaghan Medical Corporation | MONAGHAN MEDICAL CORPORATION | 2020-07-30 |
| 00863034000329 | ANEclear | ANECARE, LLC | 2018-02-27 |
| 10863034000326 | ANEclear | ANECARE, LLC | 2018-02-27 |
| 00604351600508 | AE II BAN | Monaghan Medical Corporation | 2017-07-25 |
| 50604351600503 | AE II BAN | MONAGHAN MEDICAL CORPORATION | 2017-07-25 |