Catalog Number

1701-01

Brand Name

PeraChek

Version/Model Number

1701-01

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K980164

Product Code

LIF

Product Code Name

Dialyzer Reprocessing System

Public Device Record Key

e5e52977-ef04-4b6d-a861-2d86b449ef23

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 23, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-