Catalog Number

SUPER12606

Brand Name

HIgH-Flo™ Needle Set

Version/Model Number

SUPER12606

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

894f0709-24ed-4ad3-8bf3-065dda3f74af

Public Version Date

January 08, 2021

Public Version Number

2

DI Record Publish Date

May 16, 2019

Package DI Number

10659443002798

Quantity per Package

20

Contains DI Package

00659443002791

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton