Catalog Number

9250

Brand Name

7 in (18cm) Y-Extension Set w/ 2 check valves

Version/Model Number

9250

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

91d5d247-1474-47e6-a636-0274dcfb0ea1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 26, 2016

Package DI Number

20634624092505

Quantity per Package

50

Contains DI Package

00634624092501

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper