Stat-Check

GUDID 30889483230644

Stat-Check Adult Resuscitator with Inflatable Bag Reservoir, PEEP Valve + Adapter, Mask & MaxCap

VENTLAB, LLC

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 30889483230644
• NIH Device Record Key: a604211b-4ed7-49b0-b8cc-71a83c6f1f79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stat-Check
• Version Model Number: SC9200MBP-X
• 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

Device Dimensions

• Total Volume: 250 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889483230640 [Primary]
GS1	30889483230644 [Package]; Contains: 10889483230640; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982215

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: 2019-12-25
• Device Publish Date: 2019-12-17

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