KENAFLEXX

Basic Information

• Brand Name: KENAFLEXX
• Primary DI: 00810003750129
• Version / Model: 948460
• Catalog Number: 948560
• Company Name: KENTRON HEALTHCARE, INC.
• Labeler DUNS: 618825723
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-18
• Public Version: 1
• Public Version Date: 2018-12-19
• Public Version Status: New
• Public Device Record Key: 262d8d50-9a79-4bc4-b4cc-3629a9cdcf9b

Device Description

IV ADMINISTRATION SET, 84", 60 DROPS/ML, KENTRON GRAVITO FLOW REGULATOR, 2 KEN_SEF SPLIT SEPTUM Y SITES, 15 MICRON FILTER, BACK CHECK VALVE, KEN_ROL ROTATING MALE LUER LOCK CONNECTOR, FLOW REGULATING CONTROLLER.

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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LHI	Set, I.V. Fluid Transfer	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12170	Intravenous administration tubing extension set	A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10810003750126	GS1	CASE	50	In Commercial Distribution
Primary	00810003750129	GS1

Device Sizes

Type	Value	Unit	Text
Length	84	Inch