Catalog Number

-

Brand Name

Cascade M-4 (110V/220V)

Version/Model Number

1711000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K931956

Product Code

GKP

Product Code Name

INSTRUMENT, COAGULATION, AUTOMATED

Public Device Record Key

550e3b13-f2a2-4bd6-be17-07ab6632df01

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-