Catalog Number

1054966

Brand Name

PerforMax

Version/Model Number

PerforMax Mask, Single Patient Use, EE, INTL, Small

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"

Yes

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

K091271,K091271

Product Code

BZD

Product Code Name

VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Public Device Record Key

7698f5ec-1211-41b9-a794-d9ae2facda47

Public Version Date

January 25, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

30606959000859

Quantity per Package

10

Contains DI Package

00606959000858

Package Discontinue Date

December 31, 1999

Package Status

Not in Commercial Distribution

Package Type

Multipack