NXView Touch Monitor - NXSTAGE MEDICAL, INC.

Duns Number:088013219

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More Product Details

Catalog Number

NX3302-A

Brand Name

NXView Touch Monitor

Version/Model Number

NX3302-A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

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

KDI

Product Code Name

Dialyzer, High Permeability With Or Without Sealed Dialysate System

Device Record Status

Public Device Record Key

6a432245-d75f-4294-9caf-15ef20ed0939

Public Version Date

March 19, 2020

Public Version Number

1

DI Record Publish Date

March 11, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NXSTAGE MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 211