FDA Registration
Active
🇺🇸 United States
TRINITY MEDICAL DEVICES INC.
Reg #: 3010042047
·
FEI: 3010042047
·
Expires 2026
Products
24
Proprietary Names
6
Establishment Types
2
Classifications
24
Registration Details
- Registration Name
- TRINITY MEDICAL DEVICES INC.
- Registration Number
- 3010042047
- FEI Number
- 3010042047
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 43 Speedwell Ave., #1251
- City
- Morristown
- State
- NJ
- ZIP
- 07960
- Country
- US
Regulatory Submissions
- 510(k) Number
- K140228
Owner / Operator
- Firm Name
- Trinity Medical Devices Inc.
- Operator Number
- 10043038
- Address
- 43 Speedwell Ave., #1251
- City
- Morristown
- State
- NJ
- Postal Code
- 07960
- Country
- US
- Correspondent
- Richard Kennedy
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2018-09-04 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2013-04-29 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2017-06-29 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2017-06-29 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2017-01-16 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2017-06-29 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2017-06-29 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2013-01-21 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2013-04-29 |
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2018-07-09 |
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2017-01-16 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2013-12-16 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2013-01-21 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2017-01-02 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2013-03-27 |
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2016-12-06 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2017-01-02 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2017-02-07 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2017-06-29 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2017-06-29 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2018-07-09 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2021-03-02 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2013-03-27 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2017-01-16 |
Proprietary Names
NeoGuard Thermal Reflector
Trinity Medical Devices
Gas Sampling Line
Trinity Medical
Limboard; Neoguard
KlearTrace
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility