Monitor cart - Monitor cart. - FUJIFILM CORPORATION

Duns Number:713565195

Device Description: Monitor cart.

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More Product Details

Catalog Number

-

Brand Name

Monitor cart

Version/Model Number

DR-XD 3000MX

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

JAA

Product Code Name

System, X-Ray, Fluoroscopic, Image-Intensified

Device Record Status

Public Device Record Key

1e2135ad-c14e-428a-9cd6-24eb56167129

Public Version Date

January 05, 2022

Public Version Number

1

DI Record Publish Date

December 28, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FUJIFILM CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 43
2 A medical device with a moderate to high risk that requires special controls. 324
3 A medical device with high risk that requires premarket approval 1