Catalog Number

-

Brand Name

HealthMart

Version/Model Number

BP3NG1-1AHM

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FDA

Product Code Name

Enteroscope And Accessories

Public Device Record Key

e055fdd1-0a60-4475-bb9c-b23c133ee88d

Public Version Date

August 27, 2020

Public Version Number

2

DI Record Publish Date

July 31, 2020

Package DI Number

10052569143732

Quantity per Package

6

Contains DI Package

00052569143735

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-