Disposable Hyperinflation System

GUDID 00709078011481

Hyperinflation, System, 1/2L Bag (Letx Free), 7' O2 and Manometer, Infant Mask, 40 CM pop off Valve

WESTMED, INC.

Airway pressure monitor, non-powered

• Primary Device ID: 00709078011481
• NIH Device Record Key: c4789950-7439-4456-a60d-6e0c277d908f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Hyperinflation System
• Version Model Number: 7-N7905-I-MAN-P
• 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: true
• 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	00709078011481 [Primary]
GS1	10709078011488 [Package]; 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: 2020-12-08
• Device Publish Date: 2020-11-30

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