Catalog Number

682092

Brand Name

CRITIFLO(TM) TA4004SM (3ML/HR)

Version/Model Number

682092

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

6b5d4d4c-2cee-4e45-ae82-bece5e0122a3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

50886333620925

Quantity per Package

100

Contains DI Package

00886333620920

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tyvek Pouch