Catalog Number

-

Brand Name

6" (15 cm) Microbore Extension Set with Clamp

Version/Model Number

9065

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)

-

Over the Counter (OTC)

Yes

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

f925ff97-6905-4f93-a719-04cee5bf0467

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 13, 2017

Package DI Number

20634624090655

Quantity per Package

200

Contains DI Package

00634624090651

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper