Catalog Number

-

Brand Name

Jelco

Version/Model Number

328200

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"

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

K160235,K160235,K160235

Product Code

FOZ

Product Code Name

Catheter,intravascular,therapeutic,short-term less than 30 days

Public Device Record Key

6f60d808-4861-4dc2-8edb-b0cb662e5f05

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 01, 2016

Package DI Number

50351688081924

Quantity per Package

200

Contains DI Package

30351688081920

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE