Koala Toco®

Basic Information

• Brand Name: Koala Toco®
• Primary DI: 00814247020284
• Version / Model: KDT-1000
• Company Name: CLINICAL INNOVATIONS, LLC
• Labeler DUNS: 809524291
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 5
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 8d97ebef-8ae7-4483-a2ce-1fad790c8022

Device Description

Koala Toco® Single-Use Tocodyamometer

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: 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
HFM	Monitor, Uterine Contraction, External (For Use In Clinic)	Obstetrics/Gynecology	884.2720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37258	Tocodynamometer probe	A pressure transducer intended to be placed on the abdomen of a labouring woman to convert uterine birthing contractions to electrical signals; the signals are typically displayed by a cardiotocograph (CTG). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20814247020288	GS1		4	In Commercial Distribution
Package	10814247020281	GS1		10	In Commercial Distribution
Primary	00814247020284	GS1

Premarket Submissions

Submission Number	Supplement Number
K140163	000