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Sign in to claim this brandVentlab 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
- —
- —
- [email protected]
- 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| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ventlab | 2110 | FDA UDI | Class I | Unknown |
| Ventlab | 1400 | FDA UDI | Class I | Active |
| Ventlab | VN2100MC | FDA UDI | Class II | Active |
| Ventlab | AF3144MCP-M1M00 | FDA UDI | Class II | Active |
| Ventlab | VN5000MXP | FDA UDI | Class II | Active |
| Ventlab | VNP3100MB-2B | FDA UDI | Class II | Active |
| Ventlab | VR5700-68 | FDA UDI | Class I | Active |
| Ventlab | BT4018 | FDA UDI | Class I | Active |
| Ventlab | AF5140MB-2 | FDA UDI | Class II | Active |
| Ventlab | AF1000MBN-20 | FDA UDI | Class II | Unknown |
| Ventlab | VS0600-C | FDA UDI | Class II | Active |
| Ventlab | HS4021 | FDA UDI | Class II | Active |
| Ventlab | VR5400-68 | FDA UDI | Class I | Active |
| Ventlab | AF5040MB | FDA UDI | Class II | Active |
| Ventlab | VR5000-50 | FDA UDI | Class I | Active |
| Ventlab | AF2040MBP-E | FDA UDI | Class II | Active |
| Ventlab | VR3100-120 | FDA UDI | Class I | Active |
| Ventlab | BVM700 | FDA UDI | Class II | Active |
| Ventlab | HS4111 | FDA UDI | Class II | Active |
| Ventlab | AF2102OB | FDA UDI | Class II | Active |
| Ventlab | AF3100MB-M0 | FDA UDI | Class II | Active |
| Ventlab | AFI2142MB | FDA UDI | Class II | Active |
| Ventlab | AF5242MB | FDA UDI | Class II | Active |
| Ventlab | VR4100-20 | FDA UDI | Class I | Active |
| Ventlab | R500P21 | FDA UDI | Class II | Active |
| Ventlab | HS1150-HM | FDA UDI | Class II | Active |
| Ventlab | BT2007 | FDA UDI | Class I | Active |
| Ventlab | BT5023F | FDA UDI | Class I | Active |
| Ventlab | 2201 | FDA UDI | Class I | Active |
| Ventlab | VN3100MBP | FDA UDI | Class II | Active |
| Ventlab | br130 | FDA UDI | Class II | Active |
| Ventlab | AF1040MB-T | FDA UDI | Class II | Active |
| Ventlab | HS1530 | FDA UDI | Class II | Active |
| Ventlab | HS34311 | FDA UDI | Class II | Active |
| Ventlab | HS4241 | FDA UDI | Class II | Active |
| Ventlab | 2202 | FDA UDI | Class I | Unknown |
| Ventlab | BT5007FK | FDA UDI | Class I | Active |
| Ventlab | HS1050 | FDA UDI | Class II | Active |
| Ventlab | AF1000MX | FDA UDI | Class II | Active |
| Ventlab | AF1143MC-P | FDA UDI | Class II | Active |
| Ventlab | AF3100MBP-2 | FDA UDI | Class II | Active |
| Ventlab | VN2000MBP | FDA UDI | Class II | Active |
| Ventlab | VR5000-50-C | FDA UDI | Class I | Active |
| Ventlab | CS4001S | FDA UDI | Class II | Active |
| Ventlab | AF5100MC | FDA UDI | Class II | Active |
| Ventlab | HM30 | FDA UDI | Class II | Active |
| Ventlab | AF2142MB-M5E | FDA UDI | Class II | Active |
| Ventlab | VR0400-250 | FDA UDI | Class I | Active |
| Ventlab | HS1250-M | FDA UDI | Class II | Active |
| Ventlab | VN5000OX | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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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.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Mar 15, 2016 | Z-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, 2014 | Z-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, 2012 | Z-0177-2013 | — | terminated | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. |
| Jul 11, 2012 | Z-0172-2013 | — | terminated | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. |
| Jul 11, 2012 | Z-0176-2013 | — | terminated | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. |
| Jul 11, 2012 | Z-0179-2013 | — | terminated | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. |
| Jul 11, 2012 | Z-0174-2013 | — | terminated | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. |
| Jul 11, 2012 | Z-0180-2013 | — | terminated | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. |
| Jul 11, 2012 | Z-0175-2013 | — | terminated | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. |
| Jul 11, 2012 | Z-0170-2013 | — | terminated | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. |
| Jul 11, 2012 | Z-0173-2013 | — | terminated | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. |
| Jul 11, 2012 | Z-0181-2013 | — | terminated | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. |
| Jul 11, 2012 | Z-0171-2013 | — | terminated | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. |
| Jul 11, 2012 | Z-0178-2013 | — | terminated | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. |
| Dec 5, 2007 | Z-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, 2004 | Z-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, 2004 | Z-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, 2004 | Z-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, 2004 | Z-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, 2004 | Z-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, 2003 | Z-0982-03 | — | terminated | Printed bag with instructions to verify the pressure with a 'certified manometer' was omitted in some of the product. |