Catalog Number

4007200

Brand Name

RetroGuard Arterial Safety Valve

Version/Model Number

4007200

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

MJJ

Product Code Name

Cpb Check Valve, Retrograde Flow, In-Line

Public Device Record Key

495b6a89-8545-41ec-9059-1df1a72cf553

Public Version Date

November 13, 2019

Public Version Number

3

DI Record Publish Date

June 06, 2016

Package DI Number

20634624472000

Quantity per Package

50

Contains DI Package

10634624472003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper