Catalog Number

M004PERIVAC1S0

Brand Name

PeriVac™ Kit

Version/Model Number

00884450486115

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

PXU

Product Code Name

Fluid drainage tray

Public Device Record Key

546d73d3-e4b3-400d-9d67-ef67ad039d4d

Public Version Date

March 23, 2021

Public Version Number

3

DI Record Publish Date

December 22, 2020

Package DI Number

10884450486112

Quantity per Package

4

Contains DI Package

00884450486115

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-