Jaeger 172520

GUDID 04250892902838

MasterScreen PFT

Vyaire Medical GmbH

Pulmonary function analysis system, adult

• Primary Device ID: 04250892902838
• NIH Device Record Key: 94445c56-254a-4d9f-8ef6-840ab84de9eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jaeger
• Version Model Number: 172520
• Catalog Number: 172520
• 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@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu.jae@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu.jae@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu.jae@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu.jae@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu.jae@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu.jae@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu.jae@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu.jae@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu.jae@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu.jae@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu.jae@vyaire.com
• Phone: +499314972127
• Email: support.rt.eu.jae@vyaire.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250892902838 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122699

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: 2
• Public Version Date: 2019-03-18
• Device Publish Date: 2019-01-23

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• 04250892905402: Oxycon Mobile
• 04250892905365: APS Pro SA
• 04250892905358: APS Pro SA
• 04250892905341: APS Pro SA
• 04250892905334: MasterScreen Pneumo
• 04250892905327: MasterScreen Pneumo
• 04250892905310: MasterScreen Pneumo
• 04250892905303: MasterScreen Pneumo
• 04250892905297: MasterScreen Pneumo
• 04250892905280: MasterScreen Pneumo
• 04250892905273: MasterScreen Pneumo
• 04250892905266: MasterScreen Pneumo
• 04250892905259: MasterScreen IOS
• 04250892905242: MasterScreen IOS
• 04250892905235: MasterScreen IOS
• 04250892905198: MasterScreen Body/Diff
• 04250892905181: MasterScreen Body/Diff
• 04250892905174: MasterScreen Body/Diff
• 04250892905167: MasterScreen Body/Diff
• 04250892905143: MasterScreen Body/Diff
• 04250892905136: MasterScreen Body/Diff
• 04250892905129: MasterScreen PFT
• 04250892905112: MasterScreen PFT
• 04250892905105: MasterScreen PFT
• 04250892905099: MasterScreen PFT
• 04250892905082: MasterScreen PFT
• 04250892905051: MasterScreen CPX
• 04250892905044: MasterScreen CPX
• 04250892905037: MasterScreen CPX
• 04250892905020: MasterScreen PAED
• 04250892905013: MasterScreen PAED
• 04250892905006: Masterscreen BabyBody
• 04250892904993: Masterscreen BabyBody
• 04250892902975: APS Pro SA
• 04250892902968: APS Pro SA
• 04250892902951: APS Pro SA
• 04250892902920: MasterScreen Body/Diff
• 04250892902913: MasterScreen Body/Diff
• 04250892902906: MasterScreen Body/Diff
• 04250892902890: MasterScreen Body/Diff
• 04250892902883: MasterScreen Body/Diff
• 04250892902876: MasterScreen Body/Diff
• 04250892902869: MasterScreen Body/Diff
• 04250892902852: MasterScreen Body/Diff
• 04250892902845: MasterScreen PFT
• 04250892902838: MasterScreen PFT
• 04250892902821: MasterScreen PFT
• 04250892902814: MasterScreen PFT
• 04250892902807: MasterScreen PFT
• 04250892902791: MasterScreen PFT