Catalog Number

-

Brand Name

Antmed

Version/Model Number

HBF050

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

K131770,K131770,K131770

Product Code

DQO

Product Code Name

Catheter, Intravascular, Diagnostic

Public Device Record Key

30933898-abbd-41e9-8c87-6cd2baba8e86

Public Version Date

October 31, 2018

Public Version Number

4

DI Record Publish Date

January 11, 2017

Package DI Number

06945764413472

Quantity per Package

4

Contains DI Package

06945764412475

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-