FDA Registration
Active
🇺🇸 United States
Draeger Alcotest 5820
Reg #: 3009348423
·
FEI: 3009348423
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DRAEGER, INC.
- Registration Number
- 3009348423
- FEI Number
- 3009348423
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7256 S. Sam Houston W. Parkway, Suite 100
- City
- Houston
- State
- TX
- ZIP
- 77085
- Country
- US
Owner / Operator
- Firm Name
- Draeger, Inc.
- Operator Number
- 10052404
- Address
- 3135 Quarry Road
- City
- Telford
- State
- PA
- Postal Code
- 18969
- Country
- US
- Correspondent
- Michael A Kelhart
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Devices, Breath Trapping, Alcohol | DJZ | Class 1 | Clinical Toxicology | No | 2016-07-25 |
Proprietary Names
Draeger Alcotest 5820
Draeger Alcotest 3820
Draeger Alcotest 5000
Establishment Types
Complaint File Establishment per 21 CFR 820.198