Catalog Number

01831

Brand Name

Hokanson

Version/Model Number

MD35 Doppler Barrel

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 20, 2020

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

513b80f6-035e-413d-9f95-dd7b863590d4

Public Version Date

September 24, 2020

Public Version Number

5

DI Record Publish Date

August 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-