Vital Signs™

Basic Information

• Brand Name: Vital Signs™
• Primary DI: 10190752181380
• Version / Model: 9446-911
• Catalog Number: 9446-911
• Company Name: Vyaire Medical Oy
• Labeler DUNS: 368457563
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-15
• Public Version: 1
• Public Version Date: 2020-12-23
• Public Version Status: New
• Public Device Record Key: 190c1a5f-aa19-4fb0-9308-1b6479a82f37

Device Description

Cardiac output in-line injectate probe for GE monitors, Merit Medical CritiKit, 0.9 m/3 ft

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: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	870.1230	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62220	Injectate temperature probe	A non-sterile, non-patient contact device intended to be connected to a parent temperature display/monitor (not included) to measure the temperature of a vascular injectate solution (and/or injectate cooling bath) prior to its introduction into the vasculature (e.g., as part of thermodilution-based cardiac output monitoring); it is not intended to contact the injectate directly. It is typically a metal probe with a sensor and connection cable. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10190752181380	GS1
Previous	10190752125629	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -22 – 140 Degrees Fahrenheit