Catalog Number

-

Brand Name

JMS HARMONY A.V.FISTULA NEEDLE SET

Version/Model Number

827-1500-33

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

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

5d3f4ef9-bdb9-4a00-a405-99e3b4b40fab

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 12, 2016

Package DI Number

58888483005470

Quantity per Package

300

Contains DI Package

08888483005475

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-