Catalog Number

01832

Brand Name

Hokanson

Version/Model Number

MD35/CW1A/TL400 Doppler Barrel

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

K896034

Product Code

DSB

Product Code Name

Plethysmograph, Impedance

Public Device Record Key

29be5fa4-1117-420f-9f04-3f90895a1697

Public Version Date

September 24, 2020

Public Version Number

2

DI Record Publish Date

February 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-