AirLife™ M1003346

GUDID 20889483601508

AirLife™ Uni-Filter Junior, Disposable

AirLife Finland Oy

Microbial medical gas filter, single-use

• Primary Device ID: 20889483601508
• NIH Device Record Key: 9c1e56b4-0fe4-4252-bea6-41c48375e033
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AirLife™
• Version Model Number: M1003346
• Catalog Number: M1003346
• Company DUNS: 368457563
• Company Name: AirLife Finland Oy
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752139787 [Previous]
GS1	10889483601501 [Primary]
GS1	20889483601508 [Package]; Contains: 10889483601501; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043120

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

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: 2025-04-08
• Device Publish Date: 2025-03-31

On-Brand Devices [AirLife™]

• 10889483587959: AirLife™ Infant Skin Temperature Probe, Reusable (Lullaby™, Care Plus™)
• 20889483587901: AirLife™ Infant Skin Temperature Probe, Single Patient Use (Lullaby™, Care Plus™)
• 20889483587888: AirLife™ Infant Skin Temperature Probe, Single Patient Use (Lullaby™, Care Plus™)
• 10889483577387: AirLife™ Infant Skin Temperature Probe, Reusable (Giraffe™, Panda™)
• 20889483577377: AirLife™ Infant Skin Temperature Probe, Single Patient Use (Giraffe™, Panda™)
• 20889483577360: AirLife™ Infant Skin Temperature Probe, Single Patient Use (Giraffe™, Panda™)
• 10889483586679: AirLife™ Edith 1500 HME with Memoflex, Disposable
• 10889483586617: AirLife™ Edith 1500 HME, Disposable
• 10889483586600: AirLife™ Edith 500 HME, Disposable
• 10889483586594: AirLife™ Edith 1000 HME, Disposable
• 10889483586587: AirLife™ EdithFlex HME with Integrated Flexible Tube, Disposable
• 10889483586532: AirLife™ EdithTrach HME for Spontaneously Breathing Patients, Disposable
• 20889483602536: AirLife™ HMEF 750
• 20889483602529: AirLife™ HMEF 1000, Disposable
• 20889483601577: AirLife™ Angled HMEF 750/S
• 20889483601515: AirLife™ HMEF 750/S, Disposable
• 20889483601508: AirLife™ Uni-Filter Junior, Disposable
• 20889483601492: AirLife™ Mini-Filter/S, Disposable
• 20889483601584: AirLife™ Angled Uni-Filter/S, Disposable
• 20889483601560: AirLife™ Angled HMEF 1000/S
• 20889483601522: AirLife™ HMEF 750/S With Memoflex Tube
• 20889483590598: AirLife™ Uni-Filter/S with Memoflex, Disposable
• 20889483590581: AirLife™ HMEF 1000/S With Flexible Tube and Elbow Connector, Disposable
• 20889483590000: AirLife™ HMEF Mini/S, Disposable
• 10889483586686: AirLife™ HMEF 1000/S With Memoflex Tube, Dispoable
• 10889483586662: AirLife™ HMEF 1000/S and Flexible Tube, Disposable
• 10889483586655: AirLife™ HMEF 1000/S With Flexible Tube, Disposable
• 10889483586648: AirLife™ HMEF 500/S With Memoflex Tube, Disposable
• 10889483586631: AirLife™ HMEF 500/S Disposable
• 10889483586624: AirLife™ HMEF 1000/S, Disposable
• 10889483586563: AirLife™ Uni-Filter/S, Disposable
• 10889483586556: AirLife™ Uni-Filter, Disposable
• 10889483586549: AirLife™ HMEF 1000/S With Flexible Tube and Double Swivel Elbow, Disposable