Catalog Number

-

Brand Name

Q2 IV Administration Set

Version/Model Number

ASV101Y

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

K162304

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

e29c5c23-6493-418b-a999-64bd3411bd2e

Public Version Date

July 03, 2020

Public Version Number

1

DI Record Publish Date

June 25, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-