FDA Registration
Active
🇺🇸 United States
MERLYN ASSOCIATES, INC.
Reg #: 3005160810
·
FEI: 3005160810
·
Expires 2026
Products
7
Proprietary Names
10
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- MERLYN ASSOCIATES, INC.
- Registration Number
- 3005160810
- FEI Number
- 3005160810
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2850 South Harbor Blvd.
- City
- Santa Ana
- State
- CA
- ZIP
- 92704
- Country
- US
Regulatory Submissions
- 510(k) Number
- K042683
Owner / Operator
- Firm Name
- MERLYN ASSOCIATES, INC.
- Operator Number
- 9071259
- Address
- 2850 South Harbor Blvd., --
- City
- Santa Ana
- State
- CA
- Postal Code
- 92704
- Country
- US
- Correspondent
- Neeka - Delaney
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2024-12-27 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2024-12-27 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2020-12-25 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2006-05-04 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2005-03-11 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2024-12-27 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2024-12-27 |
Proprietary Names
Disposable Air Cushion Face Mask
Oxygen Mask
Merlyn Reservoir
Merlyn Wound Drain
ENDOMASK ESSENTIAL
ENDOMASK ECLIPSE
ENDOMASK ELITE
ENDOTUBE ENDOTRACHEAL TUBES
Suction Yankaur Tubing
Suction Tubing
Establishment Types
Complaint File Establishment per 21 CFR 820.198