Kendall

Basic Information

• Brand Name: Kendall
• Primary DI: 10884521643604
• Version / Model: 56311
• Catalog Number: 56311
• Company Name: Cardinal Health, Inc.
• Labeler DUNS: 080935429
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-26
• Public Version: 5
• Public Version Date: 2023-05-01
• Public Version Status: Update
• Public Device Record Key: debf1346-a822-43b3-ade9-a6c606cdc62b
• Distribution End Date: 2023-04-30

Device Description

Intrauterine Pressure Catheter Cable Fetal Monitor

Device Characteristics

• Single Use: No
• 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: No
• 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
KXO	MONITOR, PRESSURE, INTRAUTERINE	Obstetrics/Gynecology	884.2700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36862	Patient monitoring system module, interfacing	A small unit dedicated to making communication possible between the patient monitoring system and other independent devices (e.g., ventilator, infusion pump, gas analyser, display monitors) connected to the same patient, creating an interface. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device) by providing connection between disparate devices. It may also be known as a medical information bus protocol.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521643604	GS1

Storage Conditions

• Type: Special Storage Condition, Specify