Catalog Number

-

Brand Name

Jelco

Version/Model Number

338300

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

K012128,K012128,K012128

Product Code

FOZ

Product Code Name

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

Public Device Record Key

e642cfc5-2138-475a-bb28-ae140ae0d469

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

January 04, 2017

Package DI Number

50351688071567

Quantity per Package

4

Contains DI Package

30351688071563

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON