Catalog Number

-

Brand Name

Sleep Profiler

Version/Model Number

SP40-4101

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

-

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

K152040,K152040,K152040

Product Code

OLV

Product Code Name

Standard Polysomnograph With Electroencephalograph

Public Device Record Key

99c8da6c-0ea2-4595-a279-37b2574bb410

Public Version Date

January 18, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20851113007219

Quantity per Package

50

Contains DI Package

00851113007215

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Kit of 50 Headbands