Catalog Number

-

Brand Name

Biotronix Healthcare IV Catheters

Version/Model Number

GEP050020-A

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

K142797,K142797,K142797

Product Code

FOZ

Product Code Name

Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Public Device Record Key

f74d3938-8cc8-41e0-9377-931144e4a182

Public Version Date

December 24, 2019

Public Version Number

2

DI Record Publish Date

October 03, 2019

Package DI Number

20858835007923

Quantity per Package

40

Contains DI Package

10858835007926

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case