MALLINCKRODT HOSPITAL PRODUCTS, INC.

FDA Device Registration & Listing · Hazelwood, MO, US · Registration 3009140376

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009140376
FEI Number
3009140376
Entity Name
MALLINCKRODT HOSPITAL PRODUCTS, INC.
City/State/Country
Hazelwood, MO, US
Establishment Address
675 McDonnell Blvd, Hazelwood, MO 63042, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Mallinckrodt Hospital Products, Inc (Owner Number: 1925021)
Owner / Operator Contact Address
6603 Femrite Drive, Madison, WI 53718, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Recothrom Xenotron I Xenon (Xe 133) Gas Dispenser Shield, vial Ultravent

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2016-10-19
IYT System, Rebreathing, Radionuclide Radiology Class 2 892.1390 2007-11-15
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2012-12-05
IWW Shield, Vial Radiology Class 1 892.6500 1992-12-01
CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer) Anesthesiology Class 1 868.5640 1992-12-01

Official Correspondent

David Trueblood

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Mallinckrodt Hospital Products, 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
K881095 CooperVision, Inc. KOI(TM) INSTRUMENT TRAYS 1988-04-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0036-2010 Alphatec Spine, Inc. 1
ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009140376. Last updated year: 2026. Please use registration number 3009140376 when referencing this establishment in official correspondence.
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