Catalog Number

ICCU 020

Brand Name

IRRAflow®

Version/Model Number

ICCU 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

-

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

bb0341f3-8534-442d-b153-a86a48f16122

Public Version Date

February 22, 2019

Public Version Number

1

DI Record Publish Date

January 22, 2019

Package DI Number

10868643000408

Quantity per Package

1

Contains DI Package

00868643000401

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bov