FDA Registration
Active
🇺🇸 United States
DeVilbiss Healthcare LLC.
Reg #: 2515872
·
FEI: 2515872
·
Expires 2026
Products
7
Proprietary Names
16
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- DeVilbiss Healthcare LLC.
- Registration Number
- 2515872
- FEI Number
- 2515872
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 100 Devilbiss Dr
- City
- SOMERSET
- State
- PA
- ZIP
- 15501
- Country
- US
Regulatory Submissions
- 510(k) Number
- K250805
Owner / Operator
- Firm Name
- Drive DeVilbiss Healthcare
- Operator Number
- 10032050
- Address
- 99 Seaview Blvd
- City
- Port Washington
- State
- NY
- Postal Code
- 11050
- Country
- US
- Correspondent
- Susan Scott
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Generator, Oxygen, Portable | CAW | Class 2 | Anesthesiology | No | 2026-04-28 |
| Compressor, Air, Portable | BTI | Class 2 | Anesthesiology | No | 2016-09-20 |
| Adaptor, Recreational | ILT | Class 1 | Physical Medicine | No | 2025-09-09 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2010-04-05 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2017-03-09 |
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | JCX | Class 2 | General, Plastic Surgery | No | 2010-04-05 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2010-04-05 |
Proprietary Names
DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)
Traveler
NexStride
Pulmo-Neb
Pulmo-Aide
DeVilbiss 4650 Series Pulmo-Mate
Drive DeVilbiss iGo 2 Portable Oxygen Concentrator
Suction Canister
DeVilbiss 5650 Series Pulmo-Aide
DeVilbiss 73XX Series Suction Unit
10-Liter Oxygen Concentrator
5-Liter Oxygen Concentrator
DeVilbiss Model 800 Nebulizer
DeVilbiss 5 Liter Oxygen Concentrator (555)
iFill
DeVilbiss Atomizers
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device