FDA Registration
Active
🇺🇸 United States
RESPIRONICS, INC.
Reg #: 3002797442
·
FEI: 3002797442
·
Expires 2026
Products
15
Proprietary Names
101
Establishment Types
2
Classifications
15
Registration Details
- Registration Name
- RESPIRONICS, INC.
- Registration Number
- 3002797442
- FEI Number
- 3002797442
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 174 Tech Center Drive
- City
- Mount Pleasant
- State
- PA
- ZIP
- 15666
- Country
- US
Regulatory Submissions
- 510(k) Number
- K924123
Owner / Operator
- Firm Name
- Philips Medical Systems International BV
- Operator Number
- 2518422
- Address
- Veenpluis 6
- City
- Best
- State
- NL-NOTA
- Postal Code
- 5684PC
- Country
- NL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 1999-11-01 |
| Spirometer, Therapeutic (Incentive) | BWF | Class 2 | Anesthesiology | No | 2007-12-07 |
| Sv70 Ventilator | MNT | Class 2 | Anesthesiology | No | 2012-12-18 |
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2010-06-09 |
| Compressor, Air, Portable | BTI | Class 2 | Anesthesiology | No | 2007-12-07 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | Class 2 | Anesthesiology | No | 2007-12-31 |
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2007-12-31 |
| Holding Chambers, Direct Patient Interface | NVP | Class 2 | Anesthesiology | No | 2011-09-15 |
| Ventilatory Effort Recorder | MNR | Class 2 | Anesthesiology | No | 2010-08-10 |
| Ventilator, Continuous, Non-Life-Supporting | MNS | Class 2 | Anesthesiology | No | 2010-08-05 |
| Continuous, Ventilator, Home Use | NOU | Class 2 | Anesthesiology | No | 2019-08-23 |
| Automatic Event Detection Software For Polysomnograph With Electroencephalograph | OLZ | Class 2 | Neurology | No | 2007-12-31 |
| Standard Polysomnograph With Electroencephalograph | OLV | Class 2 | Neurology | No | 2007-12-31 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2019-10-09 |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | Class 2 | Anesthesiology | No | 2011-07-19 |
Proprietary Names
Sidestream Disposable Neb and Masks
Threshold Pep
DirectView Data Management System
Encore Anywhere
A40 Heated Humidifier
OMNILAB DIRECT
Universal Battery Pack (UBP2)
BiPAP A40 Ventilatory Support System
Trilogy 202 Ventilator
Trilogy Nurse Call Adaptor Cable
Innospire Essence
Innospire Elegance
ProChamber Valved Holding Chamber
REMstar Heated Humidifier
Encore/Encore Pro Data Management System
REMstar Plus CPAP
OptiChamber Diamond with Lite Touch mask
Sidestream Plus Pediatric Mask
Sidestream Plus Adult Mask
Sidestream Plus Nebulizer
Alice PDX
PC Direct
Omnilab Direct
Omnilab Advanced/Advanced +
BiPAP autoSV Advanced
System One BiPAP w/ & w/o Humidifier
DreamStation BiPAP autoSV w/ & w/o Humidifier
DreamStation BiPAP S/T w/ & w/o Humidifier
DreamStation BiPAP AVAPS w/ & w/o Humidifier
DreamWear Full Mask
DreamWear Nasal Mask
DreamWisp Nasal Mask
Pressure Transducer Airflow Sensor (PTAF)
Pro-Flow and Pro-Flow Plus Cannula Sensors
PTAF 2, 3, Lite
Innospire Mini
Wisp Youth Nasal Mask
Threshold IMT
Trilogy Evo Ventilator
Nurse Call Rj9 Adapter Cable Open
Dual Limb Active Exhalation Valve
Nurse Call Adaptor Cable Alarm Open/Closed
Trilogy EV300
12/24V Battery Cable w/terminals or adapter
External Flow Sensor Assembly Adult/Pediatric OR Pediatric/Infant
Sleepware G3
Sleepware
Alice 6 PSG Base Station LDE
LDxN
LDxS
Alice 6 Headbox LDE
LDx
Alice PSG or components
ECG wireset
Nuance and Nuance Pro Nasal Pillow Mask
Amara View FFM - RIMR, RIMP
ComfortFull FFM - RSZ
Amara FFM - RIMR, RIMP
Sidestream Reusable Neb and Masks
Therapy Mask 3100 NC/SP
REMstar/BiPAP Q-Series w/HT
BiPAP Q-Series w/HT
REMstar Q-series CPAP w/HT
BiPAP AVAPS or S/T C-Series
EncoreAnywhere
Disposable 15 mm non-heated passive and heated active circuits
Disposable 22mm non-heated passive and heated active circuits
Disposable 15mm MPV circuit
Opti Chamber Valved Holding Chamber
Stardust 2
Stardust I, II
Respironics Disposable Heated Wire Circuits
Disposable Adult/Ped Heated Active Circuit
Disposable Adult/Ped Heated Passive Circuit
Wisp Nasal Mask
Wisp SE Nasal Mask
DreamStation BiPAP Auto w/ & w/o Humidifier
Dreamstation CPAP Auto w/ & w/o Humidifier
REMstar Auto A-flex HT (Q-series)
DreamStation CPAP w/ & w/o Humidifier
Dreamstation CPAP Pro w/ & w/o Humidifier
DreamStation BiPAP Pro w/ & w/o Humidifier
DreamStation Go CPAP
DreamStation Go Auto CPAP
Dreamstation GO w/ & w/o Humidifier
DreamStation CPAP Assist
Comfort Gel Blue Nasal Mask
REMstar SE CPAP
Dorma CPAP
ComfortGel Blue SE FFM
Amara View SE FFM
Trilogy 100 Ventilator BT, U.S.
Trilogy EC Ventilator
Garbin Ventilator BT
Trilogy 100 BT International
Trilogy 100 Ventilator
Alice NightOne
A30 Heated Humidifier
BiPAP V30 Auto
BiPAP A30 Ventilatory Support System
Trilogy Evo Universal Ventilator
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device