Jaeger 982094

GUDID 14250892908110

Volume Sensor insert

Jaeger Medical GmbH

Cardiopulmonary stress exercise monitoring system

• Primary Device ID: 14250892908110
• NIH Device Record Key: c272ffcf-a842-4e70-9b37-5f4fc4f2825d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jaeger
• Version Model Number: 982094
• Catalog Number: 982094
• Company DUNS: 329769991
• Company Name: Jaeger 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	14250892908110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183567

FDA Product Code

• BZC: Calculator, Pulmonary Function Data

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: 2025-06-10
• Device Publish Date: 2025-06-02

On-Brand Devices [Jaeger]

• 04250892907383: Disposable Mouthpiece, flex
• 14250892907205: MicroGard IIC, Filter Kit
• 14250892907199: MicroGard IIB, Filter Kit
• 34250892907186: MicroGard II sample pack
• 14250892907144: MicroGard IIC, bacterial/viral filter
• 14250892907106: MicroGard IIB, bacterial/viral filter
• 14250892908141: Elbow 45°, ID 30 mm
• 14250892908134: Elbow 45°, ID 30 mm, ULTEM, especially resistant against disinfection
• 14250892908127: Adapter, ID 30 mm to ID 30 mm
• 14250892908110: Volume Sensor insert
• 14250892908103: Turbine Complete
• 14250892908097: Turbine Complete
• 04250892907321: Disposable Mouthpiece, plastic
• 14250892908073: Volume Sensor insert
• 14250892908059: Adapter, length 50 mm, OD 30 mm to ID 30 mm
• 14250892907236: Dust filter for absorber
• 14250892907021: Nose clip pad
• 14250892907014: Nose clip
• 14250892907007: Nose clip