Catalog Number

9546

Brand Name

18 in (46 cm) Q2 Extension set w/ standard bore tubing

Version/Model Number

9546

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 13, 2019

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

K800825,K800825

Product Code

FPK

Product Code Name

Tubing, Fluid Delivery

Public Device Record Key

0d95a32d-4248-4fba-aae8-a7fd702d9770

Public Version Date

June 11, 2019

Public Version Number

4

DI Record Publish Date

July 29, 2016

Package DI Number

20634624095469

Quantity per Package

50

Contains DI Package

00634624095465

Package Discontinue Date

February 13, 2019

Package Status

Not in Commercial Distribution

Package Type

Shipper