Catalog Number

-

Brand Name

JMS HARMONY A.V.FISTULA NEEDLE SET

Version/Model Number

827-1402-33

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

e2c9be67-8f5a-40a6-8bdd-968a03c603fc

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

58888483005463

Quantity per Package

2

Contains DI Package

38888483005469

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-