Vital Signs™

Basic Information

• Brand Name: Vital Signs™
• Primary DI: 10190752110700
• Version / Model: 2013069-002
• Catalog Number: 2013069-002
• 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: f6b33a34-5de4-48f3-91c6-f9290fe632f6

Device Description

Sampling Line with Male Luer and Dehumidification Tubing for CapnoFlex Module

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
CAT	Cannula, Nasal, Oxygen	Anesthesiology	868.5340	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42049	Gas dehumidification tubing set, single-use	A collection of devices intended to be used for the purpose of dehumidifying exhaled gas prior to its analysis in a gas analyser. It is composed of a length of hollow tubing made from one of several malleable or semi-rigid materials (e.g., silicone, plastic, rubber or nylon) and an integrated filter which absorbs (subtracts) the humidity from the gases before they enter the analysing chamber of the parent device. It has a limited lifetime and may be exchanged by the user, in which case it will typically be located on the outside of the parent device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50190752110708	GS1	Box	10	In Commercial Distribution
Primary	10190752110700	GS1
Previous	10885403252747	GS1

Customer Contacts

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