Catalog Number

85.1638.001

Brand Name

Multifly®-Needle

Version/Model Number

85.1638.001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 2018

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"

-

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

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

c9f8381a-c941-4ad8-8520-4132cab6353e

Public Version Date

July 23, 2020

Public Version Number

6

DI Record Publish Date

September 16, 2016

Package DI Number

04038917322409

Quantity per Package

400

Contains DI Package

04038917132336

Package Discontinue Date

September 30, 2018

Package Status

Not in Commercial Distribution

Package Type

-