UNIVERSAL FLEX2®

Basic Information

• Brand Name: UNIVERSAL FLEX2®
• Primary DI: 00612649208091
• Version / Model: XF75
• Catalog Number: XF75
• Company Name: King Systems Corporation
• Labeler DUNS: 009299017
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-13
• Public Version: 1
• Public Version Date: 2022-12-21
• Public Version Status: New
• Public Device Record Key: 2f397741-43d0-4f6f-a8b0-beb7f00e68ff

Device Description

UNIVERSAL FLEX2 EXTENSION KIT

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAI	Circuit, breathing (w connector, adaptor, y piece)	Anesthesiology	868.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37704	Anaesthesia breathing circuit, single-use	An assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00612649161761	GS1		50	In Commercial Distribution
Primary	00612649208091	GS1

Customer Contacts

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