Catalog Number

682063

Brand Name

CRITIFLO(TM) TA4005 (30ML/HR)

Version/Model Number

682063

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KRA

Product Code Name

Catheter, Continuous Flush

Public Device Record Key

5b35e80f-2b2b-4284-9414-5e982df39945

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Package DI Number

50886333620635

Quantity per Package

100

Contains DI Package

00886333620630

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tyvek Pouch