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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: —
Email: [email protected]
Phone: +1-269-873-0502
PRRC Contact: Robert Yamashita
EUDAMED SRN: US-MF-000008625
FDA FEI Number: —
DUNS Number: —

Catalogue (1040)

Page 5 of 21

Device	Model / Reference	Registries	Class	Status
Ventlab	SC7101B	FDA UDI	Class II	Active
Ventlab	VN5100MX-F	FDA UDI	Class II	Active
Ventlab	AF5140MB-T	FDA UDI	Class II	Active
Ventlab	HS4001	FDA UDI	Class II	Active
Ventlab	AFQ5140MB	FDA UDI	Class II	Active
Ventlab	AF3140MB-I	FDA UDI	Class II	Active
Ventlab	HS4151	FDA UDI	Class II	Active
Ventlab	3006HZ	FDA UDI	Class II	Active
Ventlab	AF2142MCP-D4	FDA UDI	Class II	Active
Ventlab	AF3140MB-D1	FDA UDI	Class II	Active
Ventlab	PRO-6123	FDA UDI	Class II	Active
Ventlab	2102	FDA UDI	Class I	Unknown
Ventlab	AF1103MB	FDA UDI	Class II	Active
Ventlab	R500P30	FDA UDI	Class II	Active
Ventlab	AF2140MB-E	FDA UDI	Class II	Active
Ventlab	VR1100-200	FDA UDI	Class I	Active
Horizon	9104HZ	FDA UDI	Class II	Unknown
Ventlab	AF1040MC	FDA UDI	Class II	Active
Ventlab	SS3200OB	FDA UDI	Class II	Active
Ventlab	HS34051	FDA UDI	Class II	Unknown
Ventlab	VN2002OB	FDA UDI	Class II	Active
Ventlab	FH603027	FDA UDI	Class II	Active
Ventlab	VR5500-20	FDA UDI	Class I	Active
Ventlab	VR6400-68	FDA UDI	Class I	Active
Ventlab	VC1000F	FDA UDI	Class II	Active
Ventlab	VN2000MX-K	FDA UDI	Class II	Active
Ventlab	AF1100MB-N	FDA UDI	Class II	Active
Ventlab	ST715	FDA UDI	Class II	Active
Ventlab	AF1140MB	FDA UDI	Class II	Active
Ventlab	VN3100MCP-2	FDA UDI	Class II	Active
Ventlab	AF1140MB-PWC	FDA UDI	Class II	Active
Ventlab	AF2040MBP	FDA UDI	Class II	Active
Ventlab	BT3027	FDA UDI	Class I	Active
Ventlab	AF1000MXP	FDA UDI	Class II	Active
Ventlab	812-0011-01	FDA UDI	Class I	Unknown
Ventlab	HS31050	FDA UDI	Class II	Active
Ventlab	AF3140MB-2	FDA UDI	Class II	Active
Ventlab	AF2142MBP-2	FDA UDI	Class II	Active
Ventlab	VR7700-100	FDA UDI	Class I	Active
Ventlab	FH603022	FDA UDI	Class II	Active
Ventlab	VN3100MBP-3M	FDA UDI	Class II	Active
Ventlab	VN3100MBP-2	FDA UDI	Class II	Active
Ventlab	BT3019	FDA UDI	Class I	Active
Ventlab	VN5102MC	FDA UDI	Class II	Active
Ventlab	VR5100	FDA UDI	Class I	Active
Ventlab	VN3100MBF-I	FDA UDI	Class II	Active
Ventlab	BT4022	FDA UDI	Class I	Active
Ventlab	VN3000MX	FDA UDI	Class II	Active
Ventlab	2006HZ	FDA UDI	Class II	Active
Ventlab	AF3100MBP-M01	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.

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.

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.