Vital Signs™

Basic Information

• Brand Name: Vital Signs™
• Primary DI: 10190752152915
• Version / Model: B875XXX4
• Catalog Number: B875XXX4
• Company Name: VYAIRE MEDICAL, INC.
• Labeler DUNS: 080456871
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-22
• Public Version: 1
• Public Version Date: 2022-08-30
• Public Version Status: New
• Public Device Record Key: 394faba1-b143-457d-b111-2e39df5ecba7

Device Description

Pediatric Anesthesia Breathing Circuit

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: Yes
• 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
OFP	Anesthesia breathing circuit kit (adult & pediatric)	Anesthesiology	868.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34041	Tracheobronchial suction/insufflation catheter, single-lumen	A sterile flexible tube designed for periodic tracheal and pharyngeal mucus aspiration and inflation of the lungs with a flow of gas from its distal tip. It consists of a single lumen tube for alternating suction and insufflation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50190752152913	GS1	CASE	20	In Commercial Distribution
Primary	10190752152915	GS1

Customer Contacts

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