Catalog Number

-

Brand Name

Infusion Set for Single Use

Version/Model Number

AD0101

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K162601,K162601,K162601

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

2514dd6d-fbca-4124-a60c-0ba8d7ab2f40

Public Version Date

October 10, 2022

Public Version Number

5

DI Record Publish Date

January 15, 2018

Package DI Number

06970440020125

Quantity per Package

6

Contains DI Package

06970440020019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-