FDA Registration
Active
🇺🇸 United States
CAIRE INC.
Reg #: 3009128734
·
FEI: 2129616
·
Expires 2026
Products
4
Proprietary Names
24
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- CAIRE INC.
- Registration Number
- 3009128734
- FEI Number
- 2129616
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2205 Airport Industrial Dr
- 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 | 2009-12-01 |
| Conserver, Oxygen | NFB | Class 2 | Anesthesiology | No | 2009-12-01 |
| Flowmeter, Calibration, Gas | BXY | Class 1 | Anesthesiology | No | 2016-01-14 |
Proprietary Names
FreeStyle
Focus
FreeStyle 5
Saros Oxygen System
HOMESTYLE Aspen
Helios 300 Portable
Companion 1000 and 1000T
Portable Liquid Oxygen, Spirit
Companion 21, 31, and 41
Helios 36 & 46
CR50 Ox Reg and Oxiclip PC20
NewLife Intensity
NewLife Intensity 10
VisionAire 3
VisionAire 5
NewLife Elite
VisionAire 2
VisionAire V
VisionAire
SureFlow
FreeStyle Comfort
Liberator and Stroller
Companion 5 Oxygen Concentrator
Eclipse Oxygen System, Multiple
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device