Hyperinflation (ABMU)

GUDID 05707480103027

Hyperinflation Elbow, Manometer Dock, 7' O2 and Manometer

WESTMED, INC.

Ventilator breathing circuit, single-use

• Primary Device ID: 05707480103027
• NIH Device Record Key: c5f2ff78-19a3-4a2e-a682-8542d9ebde5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hyperinflation (ABMU)
• Version Model Number: 900 000 611
• 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: true
• 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	05707480103027 [Package]; Contains: 05707480103126; Package: [12 Units]; In Commercial Distribution
GS1	05707480103126 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-27
• Device Publish Date: 2015-10-24

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