Hyperinflation (AMBU)

GUDID 05707480103133

Disposable Hyperinflation System, 1/2L Bag (Latex Free), 7' O2 and Pressure Lines, Series 900 Infant Mask

WESTMED, INC.

Ventilator breathing circuit, single-use

• Primary Device ID: 05707480103133
• NIH Device Record Key: 4be30c01-e38b-4061-b44b-35f32c47afa7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hyperinflation (AMBU)
• Version Model Number: 900 000 610
• 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	05707480103010 [Package]; Package: [12 Units]; In Commercial Distribution
GS1	05707480103133 [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

On-Brand Devices [Hyperinflation (AMBU)]

• 00612649210100: Disposable Hyperinflation System, 1/2L Bag (Latex Free), 7' O2 and Pressure Lines, Series 900 In
• 05707480103089: Disposable Hyperinflation System, 3L Bag (Latex Free), 7' O2 and Pressure Lines
• 05707480102938: Disposable Hyperinflation System, 2L Bag (Latex Free), 7' O2 and Pressure Lines
• 05707480102945: Disposable Hyperinflation System, 1/2L Bag (Latex Free), 7' O2 and Pressure Lines
• 05707480102952: Disposable Hyperinflation System, 1/2L Bag (Latex Free), 7' O2 and Manometer
• 05707480103171: Disposable Hyperinflation System, 1/2L Bag (Latex Free), 7' O2 and Pressure Lines, Series 900 In
• 05707480102969: Disposable Hyperinflation System, 1/2L Bag (Latex Free), 7' O2 and Manometer, Series 900 Neonata
• 05707480102990: Disposable Hyperinflation System, 1L Bag (Latex Free), 7' O2 and Pressure Lines
• 05707480103003: Disposable Hyperinflation System, 1L Bag (Latex Free), 7' O2 and Manometer
• 05707480103133: Disposable Hyperinflation System, 1/2L Bag (Latex Free), 7' O2 and Pressure Lines, Series 900 In
• 05707480102976: Disposable Hyperinflation System, 1/2L Bag (Latex Free), 7' O2 and Manometer, Series 900 Infant