FDA Registration
Active
🇺🇸 United States
PARI RESPIRATORY EQUIPMENT, INC.
Reg #: 2954963
·
FEI: 1000142942
·
Expires 2026
Products
6
Proprietary Names
26
Establishment Types
4
Classifications
6
Registration Details
- Registration Name
- PARI RESPIRATORY EQUIPMENT, INC.
- Registration Number
- 2954963
- FEI Number
- 1000142942
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2412 PARI Way
- City
- MIDLOTHIAN
- State
- VA
- ZIP
- 23112
- Country
- US
Regulatory Submissions
- 510(k) Number
- K112859
Owner / Operator
- Firm Name
- PRE HOLDING, INC.
- Operator Number
- 9008012
- Address
- 2412 PARI Way, --
- City
- Midlothian
- State
- VA
- Postal Code
- 23112
- Country
- US
- Correspondent
- MICHAEL N JUDGE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2012-07-30 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2006-09-15 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2006-09-27 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2005-03-07 |
| Compressor, Air, Portable | BTI | Class 2 | Anesthesiology | No | 2005-09-28 |
| Spirometer, Therapeutic (Incentive) | BWF | Class 2 | Anesthesiology | No | 2013-01-15 |
Proprietary Names
ERAPID
Filter/Valve Set
WING TIP TUBING
LC Disposable
NASAL SHOWER
Altera
Bubbles the Fish
Trio
PARI Sinus
Hyper-Sal
Vios Pro
Proneb Ultra
Magnair Nebulizer System
Lamira Nebulizer System
Proneb Max
PARI Baby Nebulizer
Zirela Nebulizer System
LC Sprint
PEP S
PARI PEP
LC Plus
Vortex
Trek S
Vios
O-PEP
SinuStar
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Device in the United States for Export Only