FDA Registration
Active
🇺🇸 United States
A3 Anesthesia Delivery System
Reg #: 2221819
·
FEI: 2221819
·
Expires 2025
Products
9
Proprietary Names
2
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- MINDRAY DS USA, Inc.
- Registration Number
- 2221819
- FEI Number
- 2221819
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 800 MACARTHUR BLVD.
- City
- Mahwah
- State
- NJ
- ZIP
- 07430
- Country
- US
Regulatory Submissions
- 510(k) Number
- K123211
Owner / Operator
- Firm Name
- Mindray DS USA, Inc.
- Operator Number
- 10025908
- Address
- 800 MacArthur Blvd
- City
- Mahwah
- State
- NJ
- Postal Code
- 07430
- Country
- US
- Correspondent
- James Clifford
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2013-02-25 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2013-02-25 |
| Gas-Machine, Anesthesia | BSZ | Class 2 | Anesthesiology | No | 2013-02-25 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2013-02-25 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2013-02-25 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2013-02-25 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2013-02-25 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2013-02-25 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2013-02-25 |
Proprietary Names
A3 Anesthesia Delivery System
A5 Anesthesia Delivery System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198