Jaeger

Basic Information

• Brand Name: Jaeger
• Primary DI: 54250892900570
• Version / Model: V-178501
• Catalog Number: V-178501
• Company Name: Vyaire Medical GmbH
• Labeler DUNS: 329769991
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-04
• Public Version: 6
• Public Version Date: 2021-03-16
• Public Version Status: Update
• Public Device Record Key: 900e5ea6-845c-4203-a078-163dbc09ccd9
• Distribution End Date: 2019-05-22

Device Description

Vyntus WALK

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQA	Oximeter	Cardiovascular	870.2700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35447	Cardiopulmonary stress exercise monitoring system computer	A dedicated computer with a specific software package installed intended to be used to interpret the various physiological parameters and waveforms generated during stress exercise testing of a patient while connected to a stress exercise monitoring system. These signals are provided by appropriate interfaced stress testing devices (e.g., an ergometer) using predefined pattern recognition techniques. The registered signals are compared to pre-established diagnostic criteria.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	54250892900570	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -30 – 70 Degrees Celsius