Catalog Number

1012637

Brand Name

PERFORMATRAK

Version/Model Number

PerformaTrak SE Mask w/Headgear, Disp, 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

K023135,K023135

Product Code

CBK

Product Code Name

VENTILATOR, CONTINUOUS, FACILITY USE

Public Device Record Key

901578a0-3d3d-4a3a-909a-f1dfbb06de0f

Public Version Date

January 25, 2021

Public Version Number

4

DI Record Publish Date

May 12, 2016

Package DI Number

30606959000705

Quantity per Package

10

Contains DI Package

00606959000704

Package Discontinue Date

December 31, 1999

Package Status

Not in Commercial Distribution

Package Type

Multipack