AirLife Anesthesia Breathing Circuit

GUDID 30889483614895

120" Expandable, Par-Wye, HMEF and B/V Filter, 3L Latex-Free Breathing Bag, 10' M/M GSL, Yankaur, Suction Tubing, Electrodes

SUNMED, LLC

Anaesthesia breathing circuit, single-use

• Primary Device ID: 30889483614895
• NIH Device Record Key: f318c4ac-d960-43a7-8180-13132f297766
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AirLife Anesthesia Breathing Circuit
• Version Model Number: B9800
• Company DUNS: 069009268
• Company Name: SUNMED, 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889483614891 [Primary]
GS1	30889483614895 [Package]; Contains: 10889483614891; Package: [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951047

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: 2024-05-27
• Device Publish Date: 2024-05-17

Devices Manufactured by SUNMED, LLC

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• 30889483563612 - BALLARD™: 2025-11-28 BALLARD™ CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS, Y-Adapter, Endotracheal
• 30889483563650 - BALLARD™: 2025-11-28 BALLARD™ CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS, Y-Adapter, Endotracheal
• 30889483563674 - BALLARD™: 2025-11-28 BALLARD™ CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS, Y-Adapter, Endotracheal
• 30889483563704 - BALLARD™: 2025-11-28 BALLARD™ CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS, Y-Adapter, Endotracheal
• 30889483563735 - BALLARD™: 2025-11-28 BALLARD™ CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS, Y-Adapter, Endotracheal
• 30889483563766 - BALLARD™: 2025-11-28 BALLARD™ CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS, Manifold, Endotracheal
• 30889483563889 - BALLARD™: 2025-11-28 BALLARD™ CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS, Elbow, Endotracheal