Catalog Number

BLUE-9

Brand Name

PREFERRED MEDICAL PRODUCTS, LLC

Version/Model Number

BLUE-9

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K863853,K863853,K863853

Product Code

JAA

Product Code Name

System, X-Ray, Fluoroscopic, Image-Intensified

Public Device Record Key

3021b52a-562a-416b-9f2c-a373a81900c1

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

August 30, 2016

Package DI Number

30680211000023

Quantity per Package

100

Contains DI Package

00680211000022

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

100 CT BOX