Catalog Number

-

Brand Name

Jelco

Version/Model Number

448211

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

-

Product Code

FOZ

Product Code Name

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

Public Device Record Key

de4d3dc6-5439-4dff-aca6-8fc78c048e2e

Public Version Date

February 12, 2020

Public Version Number

2

DI Record Publish Date

August 08, 2019

Package DI Number

55019315118560

Quantity per Package

4

Contains DI Package

35019315118566

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pallet