Catalog Number

-

Brand Name

Vario-Pedal

Version/Model Number

1501TVS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 04, 2017

Issuing Agency

In HIBCC

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"

-

For Single-Use

-

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

K071588

Product Code

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

67371d9c-c32e-42a6-ba28-08201b1ba07b

Public Version Date

August 20, 2018

Public Version Number

4

DI Record Publish Date

January 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-