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Ventlab Corp.

United States·US-MF-000008625

Last updated May 23, 2026

What Ventlab Corp. makes

Ventlab Corp. manufactures single-use manual pulmonary resuscitators, anaesthesia face masks, and anaesthesia breathing circuits. The company also produces non-ventilatory atomizers, non-powered airway pressure monitors, exhaled-gas oesophageal intubation detectors, single-use microbial medical gas filters, and basic nasal oxygen cannulas.

The company is based in the United States, and its portfolio consists of Class I and Class II medical devices. These products are listed within the FDA UDI database.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

Where is Ventlab Corp. based?

Ventlab Corp. is based in the United States. This location is confirmed by the company's official regulatory profile, which identifies the US as its primary base of operations.

What types of medical devices does Ventlab Corp. manufacture?

Ventlab Corp. manufactures a range of respiratory and anaesthesia equipment. Their product portfolio includes manual pulmonary resuscitators, anaesthesia face masks, anaesthesia breathing circuits, non-ventilatory atomizers, non-powered airway pressure monitors, exhaled-gas oesophageal intubation detectors, microbial medical gas filters, and basic nasal oxygen cannulas.

How are the devices from Ventlab Corp. classified?

The medical devices produced by Ventlab Corp. are classified as Class I and Class II. These classifications are based on the regulatory framework applied to the specific types of respiratory and anaesthesia equipment the company manufactures.

Which registries list the devices produced by Ventlab Corp.?

The devices manufactured by Ventlab Corp. are listed in the FDA UDI database. This registry is the official source for identifying the company's medical devices as required by regulatory standards.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
United States
Address
2710 Northridge Dr. NW, Suite A, Grand Rapids, United States
Website
myairlife.com
LinkedIn
—
Facebook
—
Phone
+1-269-873-0502
PRRC Contact
Robert Yamashita
EUDAMED SRN
US-MF-000008625
FDA FEI Number
—
DUNS Number
—

Catalogue (1040)

Page 3 of 21
DeviceModel / ReferenceRegistriesClassStatus
Ventlab cs4010c
FDA UDI
Class IIActive
Ventlab AF1000MB-N
FDA UDI
Class IIUnknown
Ventlab HS1050-E
FDA UDI
Class IIActive
Ventlab BR305
FDA UDI
Class IIActive
Ventlab AF1002MB
FDA UDI
Class IIActive
Ventlab 4710
FDA UDI
Class IIActive
Ventlab BT2434F
FDA UDI
Class IActive
Ventlab AF2040MBN
FDA UDI
Class IIActive
Ventlab 3040
FDA UDI
Class IActive
Ventlab VN3100MB-PW2
FDA UDI
Class IIActive
Ventlab AF5140MBP-D6
FDA UDI
Class IIActive
Ventlab VR6100-68
FDA UDI
Class IActive
Ventlab 2011HZ
FDA UDI
Class IIActive
Ventlab AF1100MBP
FDA UDI
Class IIActive
Ventlab BT2025
FDA UDI
Class IActive
Ventlab AF2142OB
FDA UDI
Class IIActive
Ventlab 4214F
FDA UDI
Class IIActive
Ventlab PRO-6102
FDA UDI
Class IIActive
Ventlab PRO-6105
FDA UDI
Class IIActive
Ventlab PRO-6121
FDA UDI
Class IIActive
SunMed LLC AF5140MBPF-G10
FDA UDI
Class IIActive
Ventlab BT2024
FDA UDI
Class IActive
Ventlab 6915
FDA UDI
Class IIActive
Ventlab AF1140MB-PW
FDA UDI
Class IIActive
Ventlab AF3140MB-2B
FDA UDI
Class IIActive
Ventlab HS4051-T
FDA UDI
Class IIUnknown
Ventlab AF5140MBN
FDA UDI
Class IIActive
Ventlab AF3140MB-D2
FDA UDI
Class IIActive
Ventlab HS4211
FDA UDI
Class IIUnknown
Ventlab FH603014
FDA UDI
Class IIActive
Ventlab, LLC AF2002MBP
FDA UDI
Class IIActive
Ventlab AF2000MB-E
FDA UDI
Class IIActive
Ventlab BT2015
FDA UDI
Class IActive
Ventlab VN2000MC
FDA UDI
Class IIActive
Ventlab AFW2142MB-2
FDA UDI
Class IIActive
Ventlab 10889483100646
FDA UDI
Class IIActive
Ventlab AF1100MC-N
FDA UDI
Class IIActive
Ventlab MQ8100S
FDA UDI
Class IIActive
Ventlab VN3100MB-M00-0
FDA UDI
Class IIActive
Ventlab AF3040MB-2
FDA UDI
Class IIActive
Ventlab AF3144MB
FDA UDI
Class IIActive
Ventlab BT2220F
FDA UDI
Class IActive
Ventlab HM20
FDA UDI
Class IIActive
Ventlab BR301
FDA UDI
Class IIActive
Ventlab VN5000MX
FDA UDI
Class IIActive
Ventlab HS31530
FDA UDI
Class IIActive
Ventlab AF2142MBP-Z
FDA UDI
Class IIActive
Ventlab BT5006
FDA UDI
Class IActive
Ventlab BT2011
FDA UDI
Class IActive
Ventlab VR5500-50
FDA UDI
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (21)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Ventlab Corp. has 21 recall records initiated between April 15, 2003, and March 15, 2016, all of which are currently in terminated status. The reasons cited for these recalls include issues with pop-off valve functionality, potential separation of the breathing bag from the bushing, non-functional CO2 indicators, missing instructions regarding manometer verification, device cracking, and potential volume leakage through the inlet valve.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

DateRecall No.ClassStatusReason
Mar 15, 2016Z-1880-2016—terminated

Stat-check CO2 indicators are non-functional. The indicator is yellow when not in use and should be purple when not in use. The yellow indicates a 5% CO2 level, cardiac massage and ventiliation being performed correctly. The color will not change during use and will not be an indicator of CO2 level or improper performance of cardiac message and ventilation.

May 16, 2014Z-1948-2014—terminated

The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force to force the duck bill valve open and therefore no air will be delivered to the victim.

Jul 11, 2012Z-0177-2013—terminated

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Jul 11, 2012Z-0172-2013—terminated

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Jul 11, 2012Z-0176-2013—terminated

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Jul 11, 2012Z-0179-2013—terminated

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Jul 11, 2012Z-0174-2013—terminated

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Jul 11, 2012Z-0180-2013—terminated

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Jul 11, 2012Z-0175-2013—terminated

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Jul 11, 2012Z-0170-2013—terminated

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Jul 11, 2012Z-0173-2013—terminated

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Jul 11, 2012Z-0181-2013—terminated

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Jul 11, 2012Z-0171-2013—terminated

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Jul 11, 2012Z-0178-2013—terminated

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Dec 5, 2007Z-2324-2008—terminated

During setup and potentially during procedures, the breathing bag can become separated from the taped bushing that is part of the breathing bag assembly.

Mar 26, 2004Z-0892-04—terminated

In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure.

Mar 26, 2004Z-0893-04—terminated

In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure.

Mar 26, 2004Z-0891-04—terminated

In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure.

Mar 26, 2004Z-0894-04—terminated

In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure.

Mar 26, 2004Z-0895-04—terminated

In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure.

Apr 15, 2003Z-0982-03—terminated

Printed bag with instructions to verify the pressure with a 'certified manometer' was omitted in some of the product.