Catalog Number

921020

Brand Name

DUPLOCATH

Version/Model Number

921020

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 01, 2017

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

K973510

Product Code

FMF

Product Code Name

Syringe, piston

Public Device Record Key

224e7b80-e2a5-4fda-8e9c-a3b0089a75ca

Public Version Date

March 29, 2021

Public Version Number

4

DI Record Publish Date

October 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-