Catalog Number

-

Brand Name

Perfusion Set 1

Version/Model Number

9021P6012

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FEN

Product Code Name

DEVICE, CYSTOMETRIC, HYDRAULIC

Public Device Record Key

6e3fcff8-7d3f-498b-a592-b5b21bf8e7e5

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Package DI Number

30627825007246

Quantity per Package

30

Contains DI Package

20627825007249

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-