FDA Registration
Active
🇺🇸 United States
CAIRE INC.
Reg #: 3004972304
·
FEI: 3004972304
·
Expires 2026
Products
4
Proprietary Names
25
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- CAIRE INC.
- Registration Number
- 3004972304
- FEI Number
- 3004972304
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2200 Airport Industrial Dr Ste 500
- City
- Ball Ground
- State
- GA
- ZIP
- 30107
- Country
- US
Regulatory Submissions
- 510(k) Number
- K020324
Owner / Operator
- Firm Name
- CAIRE Inc.
- Operator Number
- 9008476
- Address
- 2200 Airport Industrial Dr, Ste 500
- City
- Ball Ground
- State
- GA
- Postal Code
- 30107
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Generator, Oxygen, Portable | CAW | Class 2 | Anesthesiology | No | 2016-01-14 |
| Unit, Liquid-Oxygen, Portable | BYJ | Class 2 | Anesthesiology | No | 2008-12-01 |
| Flowmeter, Calibration, Gas | BXY | Class 1 | Anesthesiology | No | 2016-01-14 |
| Conserver, Oxygen | NFB | Class 2 | Anesthesiology | No | 2009-12-01 |
Proprietary Names
FreeStyle
Focus
FreeStyle 5
Companion 5 Oxygen Concentrator
Portable Liquid Oxygen, Spirit
IntenOxy 5
Helios 300 Portable
VisionAire 3
VisionAire 5
NewLife Elite
VisionAire 2
VisionAire V
VisionAire
Helios 36 & 46
NewLife Intensity
NewLife Intensity 10
HOMESTYLE Aspen
FreeStyle Comfort
Eclipse Oxygen System, Multiple
Saros Oxygen System
SureFlow
Liberator and Stroller
Companion 21, 31, and 41
CR50 Ox Reg and Oxiclip PC20
Companion 1000 and 1000T
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device