Vetnlab

GUDID 20889483111731

SAFE SPOT W/MANOMETER, MASK, PEEP AND S1 MASK

VENTLAB, LLC

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 20889483111731
• NIH Device Record Key: 9f1a42ab-bfbb-433c-9389-70180d1e2e79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vetnlab
• Version Model Number: SS3206MCP-S1
• Company DUNS: 038305402
• Company Name: VENTLAB, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Customer Support Contacts

• Phone: 800-433-2797
• Email: info@sun-med.com
• Phone: 800-433-2797
• Email: info@sun-med.com

Device Dimensions

• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Do not get wet.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Do not get wet.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889483111734 [Primary]
GS1	20889483111731 [Package]; Contains: 10889483111734; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012842

FDA Product Code

• BTM: Ventilator, Emergency, Manual (Resuscitator)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-21
• Device Publish Date: 2016-12-01

Devices Manufactured by VENTLAB, LLC

• 30889483631526 - AirFlow™: 2025-02-11 AirFlow™ Pediatric Resuscitator with Integrated Manometer, 40cm Pop-Off, Corrugated Tubing, 3 Masks and PEEP Valve
• 30889483631533 - AirFlow™: 2025-02-10 AirFlow™ Adult Resuscitator with Integrated Manometer, 40cm Pop-Off, Corrugated Tubing and PEEP Valve
• 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