Hyperinflation AMBU

GUDID 05707480137657

Disposable Hyperinflation System, 1L bag, 7' O2 and Manometer, pediatric mask, 40 cm H2O Pop-off Valve

WESTMED, INC.

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• Primary Device ID: 05707480137657
• NIH Device Record Key: 5f1eac42-91e1-48c2-bbc6-06dd7d188856
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hyperinflation AMBU
• Version Model Number: 900 000 628
• 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	05707480137640 [Primary]
GS1	05707480137657 [Package]; Contains: 05707480137640; 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: 2
• Public Version Date: 2019-11-27
• Device Publish Date: 2019-07-24

On-Brand Devices [Hyperinflation AMBU]

• 05707480137732: Disposable Hyperinflation System, 1L bag, 7' O2 and Manometer, pediatric mask, 40 cm H2O Pop-off
• 05707480137619: Disposable Hyperinflation System, 7' O2 and Manometer, 40 CM POP off Valve, Infant Mask
• 05707480137770: Disposable Hyperinflation System, 3L bag, 7' O2 and Pressure Lines, Adult mask
• 05707480137756: Disposable Hyperinflation System, 2L bag, 7' O2 and pressure lines, adult mask
• 05707480137718: Disposable Hyperinflation System, 1L Bag, 7' O2 and Manometer Infant Mask, 40 cm H2O Pop-off Val
• 05707480137657: Disposable Hyperinflation System, 1L bag, 7' O2 and Manometer, pediatric mask, 40 cm H2O Pop-off
• 05707480137596: Disposable Hyperinflation System, 1/2 Bag, 7' O2 and Manometer, Neonatal Mask, 40 cm H2O pop-off
• 05707480137534: Disposable Hyperinflation System, 1/2 Bag 7' O2 and Manometer 40 cm H2O Pop-Off Valve