Catalog Number

-

Brand Name

NxStage SINGLE NEEDLE FISTULA SET

Version/Model Number

M9-3005

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"

Yes

For Single-Use

Yes

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

FIE

Product Code Name

Needle, Fistula

Public Device Record Key

8f38af8a-d1bc-461c-b43c-686b1bdf3ca7

Public Version Date

July 14, 2020

Public Version Number

1

DI Record Publish Date

July 06, 2020

Package DI Number

10842289102597

Quantity per Package

30

Contains DI Package

00842289102590

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box