Catalog Number

-

Brand Name

Jelco

Version/Model Number

326010

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

K160235,K160235,K160235

Product Code

FOZ

Product Code Name

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

Public Device Record Key

b8864fa7-7cf1-4367-86be-214458cf2756

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

October 28, 2016

Package DI Number

55019517078396

Quantity per Package

200

Contains DI Package

35019517078392

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON