Catalog Number

-

Brand Name

Power Injectable Infusion Set

Version/Model Number

HR-044

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K090809,K090809

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

30374fd0-b552-486c-98ed-3fbf29c17724

Public Version Date

June 26, 2019

Public Version Number

4

DI Record Publish Date

March 23, 2017

Package DI Number

10816513022661

Quantity per Package

50

Contains DI Package

00816513022664

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX