APS Pro SA V-146402-03

GUDID 04250892901022

APS Pro SA

Vyaire Medical GmbH

Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated

• Primary Device ID: 04250892901022
• NIH Device Record Key: 702df0d5-e173-43c3-86a1-435735e0a76e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APS Pro SA
• Version Model Number: V-146402-03
• Catalog Number: V-146402-03
• Company DUNS: 329769991
• Company Name: Vyaire Medical GmbH
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.c
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu.jae@carefusion.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250892901022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001502

FDA Product Code

• BZC: Calculator, Pulmonary Function Data

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: 2019-03-18
• Device Publish Date: 2017-04-10

On-Brand Devices [APS Pro SA]

• 04250892901022: APS Pro SA
• 04250892900940: APS Pro SA