Catalog Number

-

Brand Name

Disposable Valve Sets

Version/Model Number

MD-B-AW01

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

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

K192258,K192258,K192258

Product Code

ODC

Product Code Name

Endoscope Channel Accessory

Public Device Record Key

8ab1202a-1914-458e-83cc-6b09daab26ff

Public Version Date

July 18, 2022

Public Version Number

3

DI Record Publish Date

April 23, 2020

Package DI Number

16970401815095

Quantity per Package

50

Contains DI Package

06970401815081

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box