Catalog Number

00-5150-975-00

Brand Name

PULSAVAC®

Version/Model Number

00-5150-975-00

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

FQH

Product Code Name

LAVAGE, JET

Public Device Record Key

6052995b-da1e-4a93-b545-45e2c51f4aae

Public Version Date

November 06, 2020

Public Version Number

4

DI Record Publish Date

June 01, 2016

Package DI Number

00889024380134

Quantity per Package

10

Contains DI Package

00889024375253

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX