Hyperinflation

GUDID 05707480137510

Hyperinflation System, 1/2L Bag (not made with latex), 7' O2 and Pressure Lines, 40 cm H2O pop-valve

WESTMED, INC.

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• Primary Device ID: 05707480137510
• NIH Device Record Key: d63b153c-c6d1-489f-8f08-1b1ebec7250c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hyperinflation
• Version Model Number: 900 000 627
• 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	05707480137503 [Primary]
GS1	05707480137510 [Package]; Contains: 05707480137503; 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

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