Disposable Medical Hyperinflation System

GUDID 00709078006036

Transport Elbow, Adapter 8' Oxygen Tubing with Threaded Nut, 3L not made with latex bag

WESTMED, INC.

Ventilator breathing circuit, single-use

• Primary Device ID: 00709078006036
• NIH Device Record Key: c95d7bfd-9998-421b-8201-f72040679c77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Medical Hyperinflation System
• Version Model Number: 0426
• 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	00709078006036 [Primary]
GS1	10709078006033 [Package]; Package: [20 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-27
• Device Publish Date: 2018-09-25

Devices Manufactured by WESTMED, INC.

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