Catalog Number

PGV-20

Brand Name

PGV-20

Version/Model Number

PGV-20

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 01, 2017

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

K942613

Product Code

DPW

Product Code Name

Flowmeter, Blood, Cardiovascular

Public Device Record Key

43cafe46-7024-4fef-9c32-a745e166f865

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-