Catalog Number

SUPER52612

Brand Name

HIgH-Flo™ Needle Set

Version/Model Number

SUPER52612

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"

-

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

K180843,K180843

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

485b5b6a-0f21-40c1-89b5-4f401edfa7de

Public Version Date

January 08, 2021

Public Version Number

2

DI Record Publish Date

May 16, 2019

Package DI Number

10659443003016

Quantity per Package

10

Contains DI Package

00659443003019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton