Catalog Number

-

Brand Name

Foot control On/Off

Version/Model Number

1513TVS

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

d5261613-cb50-4584-81ac-58d8deff7a8b

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

-