Catalog Number

4390

Brand Name

Sensor

Version/Model Number

Filter 22mm .2micron PVC

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

K040595,K040595,K040595

Product Code

OLV

Product Code Name

Standard polysomnograph with electroencephalograph

Public Device Record Key

7ef13d8d-a53d-4e67-833d-5a64a4699de7

Public Version Date

March 22, 2022

Public Version Number

5

DI Record Publish Date

September 26, 2016

Package DI Number

40606959033236

Quantity per Package

10

Contains DI Package

00606959033238

Package Discontinue Date

December 31, 1999

Package Status

Not in Commercial Distribution

Package Type

Multipack