Hyperinflation

GUDID 00709078063800

Disposable Hyperinflation System, 1L Breathing Bag (Latex Free), 7' O2 and Manometer

WESTMED, INC.

Ventilator breathing circuit, single-use

• Primary Device ID: 00709078063800
• NIH Device Record Key: 014a1512-d538-4c7e-a122-ab7ffcd847b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hyperinflation
• Version Model Number: 7-N7901-MAN
• 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: 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	00709078063800 [Primary]
GS1	20709078063804 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-27
• Device Publish Date: 2015-10-24

On-Brand Devices [Hyperinflation]

• 20709078081846: Disposable Hyperinflation System, 1/2L Breathing Bag (Latex Free), 7' O2 and Pressure Lines, Ser
• 20709078063897: Disposable Hyperinflation System, 1/2L Breathing Bag (Latex Free), 7' O2 and Manometer, 40cm Pop
• 20709078063866: Disposable Hyperinflation System, 1/2L Breathing Bag (Latex Free), 7' O2 and Pressure Lines, Ser
• 00709078063855: Disposable Hyperinflation System, 1/2L Breathing Bag (Latex Free), 7' O2 and Pressure Lines, Ser
• 20709078063835: Disposable Hyperinflation System, 1/2L Breathing Bag (Latex Free), 7' O2 and Manometer, Series 9
• 20709078063828: Disposable Hyperinflation System, 1/2L Breathing Bag (Latex Free), 7' O2 and Manometer
• 00709078063817: Disposable Hyperinflation System, 1/2L Breathing Bag (Latex Free), 7' O2 and Manometer, Seires 9
• 00709078063800: Disposable Hyperinflation System, 1L Breathing Bag (Latex Free), 7' O2 and Manometer
• 20709078060308: Hyperinflation Elbow, 7' O2 and Pressure Lines
• 20709078060193: Disposable Hyperinflation System, 2L Breathing Bag (Latex Free), 7' KROT
• 20709078060100: Disposable Hyperinflation System, 1/2L Breathing Bag (Latex Free), 7' O2 and Pressure Lines, Ser
• 20709078060087: Disposable Hyperinflation System, 3L Breathing Bag (Latex Free), 7' O2 and Pressure Lines
• 00709078060069: Disposable Hyperinflation System, 2L Breathing Bag (Latex Free), 7' O2 and Pressure Lines
• 00709078060045: Disposable Hyperinflation System, 1L Breathing Bag, (Latex Free) 7' O2 and Pressure Lines
• 20709078060025: Disposable Hyperinflation System, 1/2L Breathing Bag (Latex Free), 7' O2 and Pressure Lines
• 20709078060018: Disposable Hyperinflation System, 1/2L Breathing Bag (Latex Free), 7' O2 and Pressure Lines
• 10709078001670: Disposable Hyperinflation System,Transport elbow, adapter, 8' oxygen tubing with threaded nut
• 10709078001663: Disposable Medical Hyperinflation System: Transport elbow, 8' oxygen tubing with threaded nut
• 05707480137695: Hyperinflation System, 1L Bag (not made with latex), 7' O2 and Pressure Lines, Pediatric Mask, 4
• 05707480137671: Hyperinflation System, 1L Bag (not made with latex), 7' O2 and Pressure Lines, Infant Mask, 40 c
• 05707480137510: Hyperinflation System, 1/2L Bag (not made with latex), 7' O2 and Pressure Lines, 40 cm H2O pop-v