Vital Signs™

Basic Information

• Brand Name: Vital Signs™
• Primary DI: 10190752110762
• Version / Model: 415036-002
• Catalog Number: 415036-002
• Company Name: Vyaire Medical Oy
• Labeler DUNS: 368457563
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-27
• Public Version: 1
• Public Version Date: 2020-12-07
• Public Version Status: New
• Public Device Record Key: 320a730a-67c0-4d95-b2a1-2fa4114ed674

Device Description

CAPNOSTAT Pediatric/Infant Airway Adapter, Disposable

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
BZA	Connector, Airway (Extension)	Anesthesiology	868.5810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46821	Carbon dioxide cuvette, single-use	A device intended to be used with a mainstream carbon dioxide (CO2) sensor for the determination of CO2 concentration in gases expired from a patient. It is designed as a small, plastic, open-ended vessel with a clear optic window (cuvette) for the acceptance of an infrared sensor that is slotted over the outside of the window section. It typically has connector ports that enable it to be connected into a breathing system (e.g., an anaesthesia or critical care ventilation system). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50190752110760	GS1	Box	10	In Commercial Distribution
Primary	10190752110762	GS1

Customer Contacts

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