Catalog Number

MEN01

Brand Name

RocaFlow Irrigation warming System

Version/Model Number

MEN01US-245

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

-

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

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Public Device Record Key

9840e2e5-087b-4e0c-a93d-fa9745c946a6

Public Version Date

November 11, 2019

Public Version Number

2

DI Record Publish Date

October 29, 2019

Package DI Number

03700512956181

Quantity per Package

1

Contains DI Package

03700512955184

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box