FDA Registration
Active
🇺🇸 United States
DRAEGER MEDICAL SYSTEMS, INC.
Reg #: 2510954
·
FEI: 2510954
·
Expires 2026
Products
5
Proprietary Names
9
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- DRAEGER MEDICAL SYSTEMS, INC.
- Registration Number
- 2510954
- FEI Number
- 2510954
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3135 QUARRY RD.
- City
- Telford
- State
- PA
- ZIP
- 18969
- Country
- US
Regulatory Submissions
- 510(k) Number
- K120642
Owner / Operator
- Firm Name
- Draeger Medical Systems, Inc.
- Operator Number
- 9070398
- Address
- 6 Tech Drive
- City
- Andover
- State
- MA
- Postal Code
- 01810
- Country
- US
- Correspondent
- Melissa Gray
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Warmer, Infant Radiant | FMT | Class 2 | General Hospital | No | 2013-12-03 |
| Incubator, Neonatal Transport | FPL | Class 2 | General Hospital | No | 2007-12-14 |
| Incubator, Neonatal | FMZ | Class 2 | General Hospital | No | 2018-05-02 |
| Unit, Neonatal Phototherapy | LBI | Class 2 | General Hospital | No | 2018-05-02 |
| Bilirubin (Total And Unbound) In The Neonate Test System | MQM | Class 1 | Clinical Chemistry | No | 2014-11-19 |
Proprietary Names
RW Resuscitaire
TI500 Globetrotter Transport System
Isolette 8000 plus Infant Incubator
BiliLux Phototherapy Light
Isolette 8000 plus
Babyroo TN300
TI500 Isolette Infant Incubator
Jaundice Meter-JM105
C2HS Isolette Infant Incubator
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device