Catalog Number

VP8XS-USA

Brand Name

DOPPLEX

Version/Model Number

VP8XS-USA

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K183574

Product Code

JAF

Product Code Name

Monitor, Ultrasonic, Nonfetal

Public Device Record Key

cf4bfdbe-a98e-486e-8b75-dbaada10eed8

Public Version Date

February 25, 2020

Public Version Number

1

DI Record Publish Date

February 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-