AirFlow

GUDID 30889483565647

AirFlow Pediatric Resuscitator with Integrated Manometer, B/V Filter, 40cm Pop-Off, Bag Reservoir, Strap, Gas Sampling Line, and Size 4 & 5 Masks

VENTLAB, LLC

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 30889483565647
• NIH Device Record Key: cd19dc16-d28d-4716-84ed-02305882e9cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AirFlow
• Version Model Number: AF2142MBS-45E
• Company DUNS: 038305402
• Company Name: VENTLAB, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889483565643 [Primary]
GS1	30889483565647 [Package]; Contains: 10889483565643; Package: Case [10 Units]; In Commercial Distribution

FDA Product Code

• BTM: Ventilator, Emergency, Manual (Resuscitator)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-22
• Device Publish Date: 2023-12-14

Devices Manufactured by VENTLAB, LLC

• 10889483555675 - Ventlab: 2024-03-20 AirFlow Pediatric Resuscitator with Integrated Manometer, B/V Filter, 40cm Pop-Off, Bag Reservoir, Gas Sampling Line, and Size 5
• 10889483555682 - Ventlab: 2024-03-20 AirFlow Adult Resuscitator with Bag Reservoir, Gas Sampling Line, and Mask
• 10889483555699 - Ventlab: 2024-03-20 AirFlow Adult Resuscitator with B/V Filter, Bag Reservoir, Gas Sampling Line, and Mask
• 10889483555705 - Ventlab: 2024-03-20 AirFlow Adult Resuscitator with B/V Filter, Bag Reservoir, Mask, PEEP Valve, and Gas Sampling Line
• 10889483555712 - Ventlab: 2024-03-20 AirFlow Adult Resuscitator with Integrated Manometer, B/V Filter, Bag Reservoir, Gas Sampling Line, and Mask
• 10889483555729 - Ventlab: 2024-03-20 AirFlow Adult Resuscitator with Integrated Manometer, B/V Filter, Bag Reservoir, Mask, PEEP Valve, and Gas Sampling Line
• 10889483555736 - Ventlab: 2024-03-20 AirFlow Adult Resuscitator with Integrated Manometer, B/V Filter, 40cm Pop-Off, Bag Reservoir, Mask, PEEP Valve, and Gas Samplin
• 10889483555743 - Ventlab: 2024-03-20 AirFlow Pediatric Resuscitator with Bag Reservoir, Gas Sampling Line, and Mask