Catalog Number

9219

Brand Name

42 in(107cm) Extension Set w/ 2 check valves

Version/Model Number

9219

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

Product Code

FPK

Product Code Name

Tubing, Fluid Delivery

Public Device Record Key

197f5684-22c7-4d10-a75b-f3fcaebaab13

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-