CMS9000 - CMS9000 Digital Recording System - MED X CHANGE, INC.

Duns Number:051244569

Device Description: CMS9000 Digital Recording System

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More Product Details

Catalog Number

CMS9000

Brand Name

CMS9000

Version/Model Number

CMS9000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 19, 2019

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

LMB

Product Code Name

Device, Digital Image Storage, Radiological

Device Record Status

Public Device Record Key

6dfe5409-39b3-4259-8087-ad055b3563e0

Public Version Date

June 15, 2022

Public Version Number

4

DI Record Publish Date

July 12, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MED X CHANGE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 86