Catalog Number

9657

Brand Name

Checkmate Extension Set 36 inch (91cm)

Version/Model Number

9657

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

-

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

9e681a85-48c1-4123-a6bf-3b2600fc3afe

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 29, 2016

Package DI Number

20634624096572

Quantity per Package

50

Contains DI Package

00634624096578

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper