Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010939

FEI Number

3002808440

Entity Name

VBM MEDIZINTECHNIK GMBH

City/State/Country

SULZ AM NECKAR Baden-Wurttemberg, DE

Establishment Address

1, EINSTEINSTRASSE, SULZ AM NECKAR Baden-Wurttemberg 72172, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

VBM Medizintechnik GmbH (Owner Number: 8010939)

Owner / Operator Contact Address

Einsteinstrasse 1, Sulz am Neckar, DE-BW 72172, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

40-8010-044 40-8018-044 40-8010-033 35-30-255 40-0005-044 40-0005-011 40-0005-033 60-60-205 60-11-300 60-12-300 60-12-001 60-50-002 60-20-101 60-20-100 60-11-200 60-11-400 60-20-501 60-11-203 60-50-005 60-11-510 60-50-003 60-12-006 60-60-002 60-65-002 60-60-305 60-60-009 60-12-201 60-11-503 60-20-500 60-65-004 60-11-500 60-12-110 60-10-100 49-30-000 60-65-009 60-60-010 60-11-420 61-99-300 60-13-000 60-11-204 60-60-209 61-99-200 60-60-005 60-12-400 60-60-111-1 60-60-004 60-12-000 60-12-200 60-67-009 60-12-601 61-99-150 54-05-000-29 54-05-000-28 20-57-952 321000702 54-04-000-28 54-06-000-28 03-42-902 54-02-000-29 54-05-223 721 54-07-000 54-03-000-29 03-43-902 15-40-922 54-03-000-9 321900000 54-05-000-P 54-04-000 54-05-112 54-03-000 112700000 54-03-001 00-197 54-06-000 54-02-001 8401DS 34-10-006 34-10-004 34-10-005 24-00-300 20-11-222-1 20-34-728SLZ-1 20-64-612 20-34-712SLZ-1 20-34-727SLZ-1 22-50-406 13-50-999 20-36-711SLZ-1 20-18-601 23-00-728-1 21-95-722 20-10-444 20-30-722SLZ-1 20-64-528 15-50-999 20-30-712SLZ-1 20-36-710SLZ-1 21-95-719 23-00-710-1 23-00-729 20-64-700 21-95-729 20-34-729SLZ-1 23-00-710 24-00-200 20-50-580 10-12-800-VK 20-11-222 20-34-722SLZ-1 24-00-100-1 20-10-442 20-30-710SLZ-1 21-95-302 23-00-727 20-36-728SLZ-1 21-95-300 20-10-333 23-00-700-1 23-00-728 20-34-715SLZ-1 20-36-712SLZ-1 20-60-712 20-36-715SLZ-1 23-00-711-1 20-50-102 21-95-712 20-64-710 24-00-200-1 20-34-710SLZ-1 20-64-522 20-36-700SLZ-1 23-00-722 15-70-902 20-11-333 20-34-711SLZ-1 20-11-111 24-00-100 23-00-729-1 23-00-700 20-36-729SLZ-1 20-57-954 20-36-727SLZ-1 CHLLF30 15-70-901 20-34-700SLZ-1 20-36-722SLZ-1 20-64-611 20-18-602 23-00-722-1 20-64-527 24-00-300-1 23-00-711 23-00-712 20-11-111-1 20-50-506 CHLLM30 20-11-333-1 21-95-727 23-00-712-1 20-64-512 01-20-000 01-00-100 01-15-000 20-60-722 20-39-100-1 20-77-722 20-75-712 20-75-728 23-00-727-1 20-75-710 20-75-711 20-75-729 20-75-700 20-77-712 20-75-727 20-75-722 20-75-715 20-77-710 01-00-110 20-60-710 35-65-222 30-40-127 30-40-125 35-40-206 35-60-003 35-40-202 30-40-333 30-40-555 35-60-000 35-65-223 35-40-203 30-40-000 35-60-002 30-40-335 30-40-777 35-40-201 35-65-224 30-40-266 35-60-001 35-65-225 88-60-266 35-40-204 35-65-226 35-40-205 30-40-111 30-02-914-1 30-02-013-1 30-02-014-1 30-02-018-1 30-02-913-1 30-02-918-1 40-66-050-1 40-66-040-1 King LTS-D Size 2 KLTSD422 King LTS-D Size 3 KLTSD423 King LTS-D Size 0 KLTSD420 King LTS-D Size 5 KLTSD425 40-60-040-1 King LTS-D Size 1 KLTSD421 King LTS-D Size 2.5 KLTSD4225 838-857 King LTS-D Size 4 KLTSD424 838-856 838-854 838-855 838-859 838-853 838-858 30-40-420-1 40-60-050-1 30-40-400-1 40-66-060-1 30-40-440-1 40-60-060-1 89-13-007 66-00-011 66-00-043 66-00-044 66-00-045 66-00-014 66-00-041 66-00-012 66-00-013 66-00-042 66-00-015 89-13-006 57-01-300 52-15-100 52-15-200 56-02-300 58-02-050 58-02-100 58-08-100 58-08-050 57-02-050 56-01-300 57-02-100 58-08-300 57-08-100 58-01-300 57-08-050 56-02-050 56-02-100 57-08-300 70-131-44 73-532-04 78-10-000 78-30-000 78-20-000 70-231-07 77-20-000 70-231-44 70-231-04 70-131-07 70-131-04 30-64-000 88-11-001 88-11-000 88-11-002 35-70-255 35-70-155 255105 253105 90-10-003 33-90-650-1 33-70-700-1 33-92-400-1 33-91-650-1 33-41-800-1 33-40-800-1 90-10-333 90-10-222 90-10-111 90-10-002 90-10-001 90-10-444 33-42-800-1 321900030 321900020 321900010

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2006-08-10
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2006-08-10
BSK	Cuff, Tracheal Tube, Inflatable	Anesthesiology	Class 2	868.5750	2006-08-10
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2010-06-25
IPW	Orthosis, Sacroiliac, Soft	Physical Medicine	Class 1	890.3490	2008-12-01
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	Class 1	878.5910	1997-03-28
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2006-08-10
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2011-08-09
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2006-08-10
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2008-12-01
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2006-08-10
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2006-08-10
BYW	Device, Rebreathing	Anesthesiology	Class 1	868.5675	1997-08-06
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2022-01-04
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2025-08-27
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2025-08-27
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2006-08-10

Official Correspondent

Carina Bertram

US Agent Details

TINA CHEN Business: VBM MEDICAL, INC. Email: info@vbm-medical.com Phone: (317) 7761800

Related Public Records

Same Entity

VBM Medizintechnik GmbH

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
K051895	Datex-Ohmeda, Inc.	GE DATEX-OHMEDA ENGSTROM CARESTATION	2005-09-27
K082966	Covidien, Formerly Nellcor Puritan Bennett, Inc.	PB 540 VENTILATOR	2008-10-31
K012633	Respironics, Inc.	RESPIRONICS HEATED HUMIDIFIER	2002-02-28
K970478	Marquest Medical Products, Inc.	SCT 3000 HEATED HUMIDIFIER	1997-07-16

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.
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010939. Last updated year: 2026. Please use registration number 8010939 when referencing this establishment in official correspondence.