AirLife™ 2K8004

GUDID 50190752114102

Adult Manual Resuscitator • Oxygen Reservoir Bag, Adult Mask

Sunmed Group Holdings, LLC

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 50190752114102
• NIH Device Record Key: bf2b3c0a-cdc3-4197-9a37-da08b18bcf08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AirLife™
• Version Model Number: 2K8004
• Catalog Number: 2K8004
• Company DUNS: 119058668
• Company Name: Sunmed Group Holdings, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752114104 [Primary]
GS1	50190752114102 [Package]; Contains: 10190752114104; Package: Case [6 Units]; In Commercial Distribution

FDA Product Code

• OEV: Cardiopulmonary resuscitation aid kit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-12-11
• Device Publish Date: 2021-04-09

On-Brand Devices [AirLife™]

• 50190752155815: AirLife™ Aspirator Arterial Blood Sampler
• 50190752149739: Pediatric Manual Resuscitator 40” (1.0 m) Oxygen Reservoir Tubing, Masks (Toddler, Child, Adul
• 50190752132618: AirLife™ baby safe flow-inflating resuscitation device 1/2 Liter Bag
• 50190752132601: AirLife™ baby safe flow-inflating resuscitation device 1/2 Liter Bag
• 50190752114119: Adult Manual Resuscitator •Oxygen Reservoir Bag, Adult Mask, CO2Detector
• 50190752114102: Adult Manual Resuscitator • Oxygen Reservoir Bag, Adult Mask
• 10889483581995: Reduced Heparin (Arterial Blood Sampler)