Catalog Number

-

Brand Name

Benchmark MAX System

Version/Model Number

BMX96100SIM125-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

K201271

Product Code

DQY

Product Code Name

CATHETER, PERCUTANEOUS

Public Device Record Key

881a86bf-5c98-455a-a4ac-008f38b7bf2b

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

August 28, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-