AirLife™ 10608-701

GUDID 30889483572829

Isothermal Pediatric Respiratory Breathing Circuit Non-heated

Sunmed Group Holdings, LLC

Ventilator breathing circuit, single-use

• Primary Device ID: 30889483572829
• NIH Device Record Key: 6942026f-1125-4df5-939f-9a465d11789b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AirLife™
• Version Model Number: 10608-701
• Catalog Number: 10608-701
• Company DUNS: 119058668
• Company Name: Sunmed Group Holdings, 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: false
• Expiration Date: false
• 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
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752151802 [Previous]
GS1	10889483572825 [Primary]
GS1	30889483572829 [Package]; Contains: 10889483572825; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993833

FDA Product Code

• BZE: Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

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: 2025-02-20
• Device Publish Date: 2025-02-12

On-Brand Devices [AirLife™]

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• 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)
• 30889483569348: AirLife™ Adult Oxygen Mask Vinyl, Under-the-Chin Style, High Concentration Nonrebreather Mask
• 30889483599772: AirLife™ Misty Fast™ Small Volume Nebulizer With 7 foot (2.1 m) Female U/Connect-It Crush Re
• 30889483599734: AirLife™ Misty Fast™ Small Volume Nebulizer With 7 foot (2.1 m) Crush Resistant Oxygen Tubin
• 30889483595811: AirLife™ Adult Heated Wire Circuit Single-limb, Single-heated circuit
• 30889483570849: Pediatric Volumetric Incentive Spirometer
• 30889483570832: Volumetric Incentive Spirometer 2500 ml
• 30889483570825: Volumetric Incentive Spirometer
• 30889483570818: AirLife™ Volumetric Incentive Spirometer, 4000 ml
• 30889483570801: Volumetric Incentive Spirometer
• 30889483588127: AirLife™ Isothermal Breathing Circuit 1.3 m (4.5') • Infant Respiratory Circuit Non-Heated
• 30889483587274: Isothermal™ Breathing Circuit Accessory
• 30889483587168: Isothermal™ Breathing Circuit Accessory
• 30889483585751: Water Trap
• 30889483584587: Nebulizer with Air Entertainment Usable Capacity: 350 ml
• 30889483584549: AirLife™ Breathing Circuit
• 30889483584341: Isothermal™ Breathing Circuit Accessory - Special Product Request
• 30889483584082: Isothermal™ Breathing Circuit Accessory
• 30889483580770: Isothermal Breathing Circuit Accessory
• 30889483579477: Sterile Water for inhalation
• 30889483579460: Sterile Water for Inhalation
• 30889483574014: Isothermal™ Breathing Circuit Infant Respiratory Circuit Non – heated
• 30889483573376: Isothermal Breathing Circuit 1.3 m (4.5’) • Pediatric Respiratory Circuit Non-Heated
• 30889483572997: Isothermal™ Breathing Circuit Pediatric Respiratory Circuit Non heated
• 30889483572874: Isothermal™ Adult Respiratory Breathing Circuit Non-heated
• 30889483572829: Isothermal Pediatric Respiratory Breathing Circuit Non-heated
• 30889483572812: Isothermal™ Breathing Circuit Adult Respiratory Circuit Non–heated
• 30889483572683: Isothermal™ Breathing Circuit Accessory
• 30889483572614: Isothermal™ Breathing Circuit Adult Respiratory Circuit Non–heated
• 30889483572553: Isothermal Breathing Circuit Accessory - 10mm Inspiratory line Extension
• 30889483572522: Isothermal Breathing Circuit Accessory
• 30889483569911: AirLife™ Oxygen Tubing 50 feet (15.2 m) Green Crush-Resistant Lumen, Vinyl Tipped
• 30889483569881: AirLife™ Oxygen Tubing 25 feet (7.6 m) Green Crush-Resistant Lumen, Vinyl Tipped
• 30889483569829: AirLife™ Oxygen Tubing 14 feet (4.3 m) Green Crush-Resistant Lumen, Vinyl Tipped