Catalog Number

95713

Brand Name

Q2 Flexible IV Extension Set, 3 port

Version/Model Number

95713

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

K800825,K800825

Product Code

FPK

Product Code Name

Tubing, Fluid Delivery

Public Device Record Key

60fcaae8-f17f-49c1-a9ac-370050f6029a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 29, 2016

Package DI Number

20634624957132

Quantity per Package

50

Contains DI Package

00634624957138

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper