Catalog Number

1012624

Brand Name

PERFORMATRAK

Version/Model Number

PerformaTrak Mask with Headgear, Disposable, Medium, USA

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

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

K002465,K002465

Product Code

BZD

Product Code Name

VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Public Device Record Key

5fa60226-f09d-4629-871d-59bb99ae3299

Public Version Date

January 25, 2021

Public Version Number

4

DI Record Publish Date

May 12, 2016

Package DI Number

30606959000644

Quantity per Package

10

Contains DI Package

00606959000643

Package Discontinue Date

December 31, 1999

Package Status

Not in Commercial Distribution

Package Type

Multipack