Catalog Number

CLIH503X-BLUE

Brand Name

CLINICAL HEALTH SERVICES, INC.

Version/Model Number

CLIH503X-BLUE

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K012522,K012522

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

65696cff-577c-4900-b63d-2aff5478fa88

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

December 09, 2016

Package DI Number

00815290015005

Quantity per Package

4

Contains DI Package

00815290013889

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case