Koala Toco®

GUDID 20814247020288

Koala Toco® Single-Use Tocodyamometer

CLINICAL INNOVATIONS, LLC

Cardiotocograph transducer
Primary Device ID20814247020288
NIH Device Record Key8d97ebef-8ae7-4483-a2ce-1fad790c8022
Commercial Distribution StatusIn Commercial Distribution
Brand NameKoala Toco®
Version Model NumberKDT-1000
Company DUNS809524291
Company NameCLINICAL INNOVATIONS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814247020284 [Primary]
GS110814247020281 [Package]
Contains: 00814247020284
Package: [10 Units]
In Commercial Distribution
GS120814247020288 [Package]
Contains: 10814247020281
Package: [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HFMMonitor, Uterine Contraction, External (For Use In Clinic)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-01

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