Ambu 900-000-618

GUDID 20889483231538

Ambu Disposable Hyperinflation System, Hyperinflation System, 1/2L Bag, 7' O2 and Manometer, Infant Mask, 40 cm H2O Pop-Off Valve with Override

SUNMED, LLC

Ventilator breathing circuit, single-use

• Primary Device ID: 20889483231538
• NIH Device Record Key: 39e2cf10-81e9-40e8-876a-08830a81a49d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ambu
• Version Model Number: 900-000-618
• Catalog Number: 900-000-618
• 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: 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: 1-800-433-2797
• Email: info@sun-med.com
• Phone: 1-800-433-2797
• Email: info@sun-med.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05707480137602 [Previous]
GS1	10889483231531 [Primary]
GS1	20889483231538 [Package]; Contains: 10889483231531; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932709

FDA Product Code

• BZR: Mixer, Breathing Gases, Anesthesia Inhalation

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: 2025-12-29
• Device Publish Date: 2025-12-19

On-Brand Devices [Ambu]

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• 20889483231583: Ambu Disposable Hyperinflation System, Hyperinflation System, 1 L Bag, 7' O2 and Manometer, Pedi
• 20889483231538: Ambu Disposable Hyperinflation System, Hyperinflation System, 1/2L Bag, 7' O2 and Manometer, Inf
• 20889483231521: Ambu Disposable Hyperinflation System, Hyperinflation System, 1/2L Bag, 7' O2 and Manometer, Neo
• 20889483231491: Ambu Disposable Hyperinflation System, Hyperinflation System, 1/2 L Bag, 7' O2 and Manometer, 40
• 20889483222239: Ambu Disposable Hyperinflation System, Hyperinflation System, Manometer Dock, 7' O2 and Manomete
• 20889483222222: Ambu Disposable Hyperinflation System, Hyperinflation System, 1 L Bag, 7' O2 and Manometer
• 20889483222208: Ambu Disposable Hyperinflation System, Hyperinflation System, 1/2 L Bag, 7' O2 and Manometer, In
• 20889483222192: Ambu Disposable Hyperinflation System, Hyperinflation System, 1/2 L Bag, 7' O2 and Manometer, Ne
• 20889483222185: Ambu Disposable Hyperinflation System, Hyperinflation System, 1/2 L Bag, 7' O2 and Manometer
• 20889483222161: Ambu Disposable Hyperinflation System, Hyperinflation System, 2 L Bag, 7' O2 and Pressure Lines
• 20889483222154: Ambu Disposable Hyperinflation System, Hyperinflation System, 3 L Bag, 7' O2 and Pressure Lines