FDA Registration
Active
🇺🇸 United States
Vibralung® Trach Interface Kit with Aerosol Delivery System
Reg #: 3007858792
·
FEI: 3007858792
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- VIBRALUNG, INC.
- Registration Number
- 3007858792
- FEI Number
- 3007858792
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 11990 Meadowood Lane
- City
- Parker
- State
- CO
- ZIP
- 80138
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133057
Owner / Operator
- Firm Name
- VibraLung, Inc.
- Operator Number
- 10084462
- Address
- 11990 Meadowood Lane
- City
- Parker
- State
- CO
- Postal Code
- 80138
- Country
- US
- Correspondent
- Lucille E Hughes
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intra-Pulmonary Percussive Vibration (Ipv) Devices | SDT | Class 2 | Anesthesiology | No | 2022-02-24 |
Proprietary Names
Vibralung® Trach Interface Kit with Aerosol Delivery System
Vibralung® Acoustical Percussor
Vibralung® HHT Hanger
Vibralung® Treatment Control Unit
Vibralung® Patient Kit
Vibralung® Mask Interface Kit-Adult with Aerosol Delivery System
Vibralung® Patient Change Kit
Vibralung® Mask Interface Kit-Pediatric w/Aerosol Delivery System
Vibralung® Full User Kit/Travel Bag
Establishment Types
Manufacture Medical Device