Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2243252

FEI Number

2243252

Entity Name

Bayer HealthCare, LLC

City/State/Country

Morristown, NJ, US

Establishment Address

36 Columbia Rd, Morristown, NJ 07960, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Bayer Pharma, AG (Owner Number: 10045903)

Owner / Operator Contact Address

800 Dwight Way, Berkeley, CA 94710, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2017-10-31
HHS	Transcervical Contraceptive Tubal Occlusion Device	Obstetrics/Gynecology	Class 3	884.5380	2014-01-10
KZH	Introducer, Syringe Needle	General Hospital	Class 2	880.6920	2016-08-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bayer Pharma, AG

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3002808086	BAYER PHARMA, AG	Berlin, DE

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2008	Lemaitre Vascular, Inc.	2	CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05	Medrad Inc	2	Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2243252. Last updated year: 2026. Please use registration number 2243252 when referencing this establishment in official correspondence.