Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011780089

FEI Number

3011780089

Entity Name

Baldus Sedation GmbH & Co. KG

City/State/Country

Bendorf Rhineland-Palatinate, DE

Establishment Address

In der Langfuhr 32, Bendorf Rhineland-Palatinate 56170, DE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Baldus Sedation GmbH & Co. KG (Owner Number: 10062442)

Owner / Operator Contact Address

In der Langfuhr 32, Bendorf, DE-RP 56170, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222794

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
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2020-01-29
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2022-06-23
CAX	Flowmeter, Tube, Thorpe, Back-Pressure Compensated	Anesthesiology	Class 1	868.2340	2020-01-28
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Anesthesiology	Class 2	868.5330	2023-09-22
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Anesthesiology	Class 2	868.5330	2023-09-11

Official Correspondent

Lisa Baldus

US Agent Details

Joseph Latkowski Business: Air Techniques, Inc. Email: joseph.latkowski@airtechniques.com Phone: (800) 2478324

Related Public Records

Same Entity

Baldus Sedation GmbH & Co. KG

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24
Z-0036-04	VIASYS Med Systems	1	Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83120
Z-0037-04	VIASYS Med Systems	1	Sideport Kit, consisting of an adjustable sideport valve and an O2 port elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83166

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011780089. Last updated year: 2026. Please use registration number 3011780089 when referencing this establishment in official correspondence.