Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005803389

FEI Number

3005803389

Entity Name

BRYAN MEDICAL INC.

City/State/Country

Cincinnati, OH, US

Establishment Address

6100 Wooster Pike, Cincinnati, OH 45227, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Bryan Medical Inc. (Owner Number: 10029737)

Owner / Operator Contact Address

6100 Wooster Pike., Cincinnati, OH 45227, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K150951

PMA Number

N/A

All Registered Proprietary Names

Tenax Laser Resistant Endotracheal Tube Convenience Kit Tenax aeris

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OGK	Orotracheal Intubation Guide Kit	Anesthesiology	Class 2	868.1400	2021-02-04
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2020-12-04
BSK	Cuff, Tracheal Tube, Inflatable	Anesthesiology	Class 2	868.5750	2020-12-04
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2015-07-10

Official Correspondent

David Rattigan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bryan Medical 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
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
K243785	Covidien, LLC	Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced	2025-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2014	H & H Associates	2	H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part *H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708*. The product is used to maintain fracture alignment.

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1643817	ISOMEDIX OPERATIONS INC	EL PASO, TX, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005803389. Last updated year: 2026. Please use registration number 3005803389 when referencing this establishment in official correspondence.