Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010042047

FEI Number

3010042047

Entity Name

TRINITY MEDICAL DEVICES INC.

City/State/Country

Morristown, NJ, US

Establishment Address

43 Speedwell Ave., #1251, Morristown, NJ 07960, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Trinity Medical Devices Inc. (Owner Number: 10043038)

Owner / Operator Contact Address

43 Speedwell Ave., #1251, Morristown, NJ 07960, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NeoGuard Thermal Reflector Trinity Medical Devices Trinity Medical Devices Trinity Medical Devices Trinity Medical Devices Trinity Medical Devices Trinity Medical Devices Trinity Medical Devices Trinity Medical Devices Trinity Medical Devices Trinity Medical Devices Gas Sampling Line Trinity Medical Devices Trinity Medical Devices Trinity Medical Devices Trinity Medical Devices Trinity Medical Devices Trinity Medical Devices Trinity Medical

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2018-09-04
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2013-04-29
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2017-06-29
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2017-06-29
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2017-01-16
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2017-06-29
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2017-06-29
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2013-01-21
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2013-04-29
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2018-07-09
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2017-01-16
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2013-12-16
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2014-02-19
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2013-01-21
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2013-04-29
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2017-06-29
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2017-06-29
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2017-01-02
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2013-03-27

Official Correspondent

Richard Kennedy

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Trinity Medical Devices Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K233341	Covidien, LLC	Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)	2024-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010042047. Last updated year: 2026. Please use registration number 3010042047 when referencing this establishment in official correspondence.