Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011481350

FEI Number

3011481350

Entity Name

BD MEDICAL DEVELOPMENT

City/State/Country

Crown Point, IN, US

Establishment Address

1140 Millennium Dr, Crown Point, IN 46307, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BD Medical Development (Owner Number: 10092278)

Owner / Operator Contact Address

1140 Millennium Drive, Crown Point, IN 46307, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS) Tenax Laser Resistant Endotracheal Tube TUBE, TRACHEAL (W/WO CONNECTOR) Tenax Laser Resistant Endotracheal Tube CUFF, TRACHEAL TUBE, INFLATABLE Control Cric

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQJ	Implant, Absorbable, (Scleral Buckling Methods)	Ophthalmic	Class 2	886.3300	2024-12-19
BSK	Cuff, Tracheal Tube, Inflatable	Anesthesiology	Class 2	868.5750	2024-12-19
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2024-12-19
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2024-12-19

Official Correspondent

Mary Depel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BD Medical Development

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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3018226067	SHANGHAI LONGMANN TECH CO., LTD.	Shanghai, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011481350. Last updated year: 2026. Please use registration number 3011481350 when referencing this establishment in official correspondence.