Catalog Number

ICDS 020

Brand Name

IRRAflow® Cassette and Tube Set

Version/Model Number

ICDS 020

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K171880,K171880

Product Code

GWM

Product Code Name

Device, Monitoring, Intracranial Pressure

Public Device Record Key

f78b0e13-a300-4e7a-833f-24b25f9d4eb2

Public Version Date

February 22, 2019

Public Version Number

1

DI Record Publish Date

January 22, 2019

Package DI Number

10868643000415

Quantity per Package

5

Contains DI Package

00868643000418

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box