AMBU Hyperinflation System

GUDID 20889483568795

Hyperinflation System, 3L Bag 7' O2 and Pressure Lines

WESTMED, INC.

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 20889483568795
• NIH Device Record Key: 98c68004-e755-4b1c-ba60-f8439a8b2406
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMBU Hyperinflation System
• Version Model Number: 900 000 601
• 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: true
• 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	10889483542774 [Primary]
GS1	20889483568795 [Package]; Contains: 10889483542774; 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: 2026-03-13
• Device Publish Date: 2026-03-05

On-Brand Devices [AMBU Hyperinflation System]

• 20889483542962: Hyperinflation System, Manometer Dock, 7' O2 and Manometer
• 20889483542924: Hyperinflation System, 1L Bag, 7' O2 and Manometer
• 20889483542887: Hyperinflation System, 1/2L Bag, 7' O2 and Manometer, Infant Mask
• 20889483542863: Hyperinflation System, 1/2L Bag, 7' O2 and Manometer, Neonatal Mask
• 20889483542849: Hyperinflation System, 1/2L Bag, 7' O2 and Manometer
• 20889483542801: Hyperinflation System, 2L Bag, 7' O2 and Pressure lines
• 20889483568795: Hyperinflation System, 3L Bag 7' O2 and Pressure Lines
• 20889483528942: Hyperinflation System, 1L Bag, 7' O2 and Manometer, 40 cm H2O Pop-Off Valve with Override
• 20889483528867: Hyperinflation System, 1L Bag, 7' O2 and Manometer, Pediatric Mask, 40 cm H2O Pop-Off Valve with
• 20889483528751: Hyperinflation System, 1/2L Bag, 7' O2 and Manometer, Infant Mask, 40 cm H2O Pop-Off Valve with
• 20889483528737: Hyperinflation System, 1/2L Bag, 7' O2 and Manometer, Neonatal Mask, 40 cm H2O Pop-Off Valve wit
• 20889483528614: Hyperinflation System, 1/2L Bag, 7' O2 and Manometer, 40 cm H2O Pop-Off Valve with Override