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Ventlab Corp.

United States·US-MF-000008625

Last updated May 23, 2026

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 1 of 21
DeviceModel / ReferenceRegistriesClassStatus
Ventlab 2110
FDA UDI
Class IUnknown
Ventlab 1400
FDA UDI
Class IActive
Ventlab VN2100MC
FDA UDI
Class IIActive
Ventlab AF3144MCP-M1M00
FDA UDI
Class IIActive
Ventlab VN5000MXP
FDA UDI
Class IIActive
Ventlab VNP3100MB-2B
FDA UDI
Class IIActive
Ventlab VR5700-68
FDA UDI
Class IActive
Ventlab BT4018
FDA UDI
Class IActive
Ventlab AF5140MB-2
FDA UDI
Class IIActive
Ventlab AF1000MBN-20
FDA UDI
Class IIUnknown
Ventlab VS0600-C
FDA UDI
Class IIActive
Ventlab HS4021
FDA UDI
Class IIActive
Ventlab VR5400-68
FDA UDI
Class IActive
Ventlab AF5040MB
FDA UDI
Class IIActive
Ventlab VR5000-50
FDA UDI
Class IActive
Ventlab AF2040MBP-E
FDA UDI
Class IIActive
Ventlab VR3100-120
FDA UDI
Class IActive
Ventlab BVM700
FDA UDI
Class IIActive
Ventlab HS4111
FDA UDI
Class IIActive
Ventlab AF2102OB
FDA UDI
Class IIActive
Ventlab AF3100MB-M0
FDA UDI
Class IIActive
Ventlab AFI2142MB
FDA UDI
Class IIActive
Ventlab AF5242MB
FDA UDI
Class IIActive
Ventlab VR4100-20
FDA UDI
Class IActive
Ventlab R500P21
FDA UDI
Class IIActive
Ventlab HS1150-HM
FDA UDI
Class IIActive
Ventlab BT2007
FDA UDI
Class IActive
Ventlab BT5023F
FDA UDI
Class IActive
Ventlab 2201
FDA UDI
Class IActive
Ventlab VN3100MBP
FDA UDI
Class IIActive
Ventlab br130
FDA UDI
Class IIActive
Ventlab AF1040MB-T
FDA UDI
Class IIActive
Ventlab HS1530
FDA UDI
Class IIActive
Ventlab HS34311
FDA UDI
Class IIActive
Ventlab HS4241
FDA UDI
Class IIActive
Ventlab 2202
FDA UDI
Class IUnknown
Ventlab BT5007FK
FDA UDI
Class IActive
Ventlab HS1050
FDA UDI
Class IIActive
Ventlab AF1000MX
FDA UDI
Class IIActive
Ventlab AF1143MC-P
FDA UDI
Class IIActive
Ventlab AF3100MBP-2
FDA UDI
Class IIActive
Ventlab VN2000MBP
FDA UDI
Class IIActive
Ventlab VR5000-50-C
FDA UDI
Class IActive
Ventlab CS4001S
FDA UDI
Class IIActive
Ventlab AF5100MC
FDA UDI
Class IIActive
Ventlab HM30
FDA UDI
Class IIActive
Ventlab AF2142MB-M5E
FDA UDI
Class IIActive
Ventlab VR0400-250
FDA UDI
Class IActive
Ventlab HS1250-M
FDA UDI
Class IIActive
Ventlab VN5000OX
FDA UDI
Class IIActive

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.

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.