FDA Registration
Active
🇦🇺 Australia
RESMED PTY LTD.
Reg #: 3004604967
·
FEI: 3004604967
·
Expires 2026
Products
18
Proprietary Names
8
Establishment Types
3
Classifications
18
Registration Details
- Registration Name
- RESMED PTY LTD.
- Registration Number
- 3004604967
- FEI Number
- 3004604967
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1 ELIZABETH MACARTHUR DRIVE
- City
- BELLA VISTA New South Wales
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K102586
Owner / Operator
- Firm Name
- RESMED CORP.
- Operator Number
- 9002319
- Address
- 9001 Spectrum Center Blvd, --
- City
- San Diego
- State
- CA
- Postal Code
- 92123
- Country
- US
- Correspondent
- David Lanfranchi
US Agent
- Business Name
- ResMed Corp
- Contact Name
- David Lanfranchi
- Address
- 9001 Spectrum Center Blvd
- City
- San Diego
- State
- CA
- ZIP
- 92123
- Country
- US
- [email protected]
- Phone
- 858 8365000
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Support, Breathing Tube | JAY | Class 1 | Anesthesiology | No | 2016-09-08 |
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2011-04-20 |
| Ventilator, Continuous, Non-Life-Supporting | MNS | Class 2 | Anesthesiology | No | 2013-03-24 |
| Sv70 Ventilator | MNT | Class 2 | Anesthesiology | No | 2014-04-14 |
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2014-05-27 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | Class 2 | Anesthesiology | No | 2026-03-17 |
| Continuous, Ventilator, Home Use | NOU | Class 2 | Anesthesiology | No | 2020-11-10 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2015-01-19 |
| Ventilatory Effort Recorder | MNR | Class 2 | Anesthesiology | No | 2014-05-13 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2011-01-30 |
| Cabinet, Table And Tray, Anesthesia | BRY | Class 1 | Anesthesiology | No | 2010-02-21 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2013-03-17 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2023-06-01 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2007-01-25 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2013-07-28 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2004-06-18 |
| Strap, Head, Gas Mask | BTK | Class 1 | Anesthesiology | No | 2016-09-02 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2011-09-20 |
Proprietary Names
Air tubing connector
SULLIVAN NASAL CPAP SYSTEM
AirFit F20
F20 QuietAir Elbow
S8 CPAP System
VPAP ST, H4i
S8 VPAP System
RPSII
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)