Ambu Hyper System

GUDID 05707480137572

Hyperinflation System, 1/2L bag (not made with Latex), 7' O2 and pressure lines, Infant mask, 40 cm H2O pop-valve

WESTMED, INC.

Ventilator breathing circuit, single-use

• Primary Device ID: 05707480137572
• NIH Device Record Key: 728a2b41-96fb-45aa-a65b-60d4b74e66c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ambu Hyper System
• Version Model Number: 900 000 616
• Company DUNS: 092673953
• Company Name: WESTMED, INC.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05707480137565 [Primary]
GS1	05707480137572 [Package]; Contains: 05707480137565; Package: [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: 2020-02-10
• Device Publish Date: 2020-01-31

On-Brand Devices [Ambu Hyper System]

• 05707480137633: Hyperinflation System, 1L bag (not made with Latex), 7' O and Pressure lines, 40cm H2O Pop-Valve
• 05707480137572: Hyperinflation System, 1/2L bag (not made with Latex), 7' O2 and pressure lines, Infant mask, 40
• 05707480137558: Disposable Hyperinflation System, 1/2L bag (not made with latex), 7' O2 and pressure Lines, Neon