Catalog Number

-

Brand Name

XBit Series Digital Color Doppler Ultrasound System

Version/Model Number

XBit 80

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

K200780,K200780,K200780,K200780,K200780,K200780,K200780,K200780,K200780,K200780,K200780,K200780,K200780,K200780,K200780,K200780,K200780,K200780

Product Code

IYN

Product Code Name

System, Imaging, Pulsed Doppler, Ultrasonic

Public Device Record Key

fe5d8b91-497d-46ca-a21f-9ab27bcfef23

Public Version Date

September 19, 2022

Public Version Number

7

DI Record Publish Date

July 10, 2022

Package DI Number

06945121413916

Quantity per Package

1

Contains DI Package

06945121413787

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-