Catalog Number

-

Brand Name

Koala Toco®

Version/Model Number

KDT-1000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K140163,K140163,K140163

Product Code

HFM

Product Code Name

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

Public Device Record Key

8d97ebef-8ae7-4483-a2ce-1fad790c8022

Public Version Date

June 05, 2020

Public Version Number

4

DI Record Publish Date

September 01, 2016

Package DI Number

20814247020288

Quantity per Package

4

Contains DI Package

10814247020281

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-