Sleep Profiler PSG2 - Effort Cable Standard Kit - ADVANCED BRAIN MONITORING, INC.

Duns Number:969842715

Device Description: Effort Cable Standard Kit

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More Product Details

Catalog Number

-

Brand Name

Sleep Profiler PSG2

Version/Model Number

UN03-4003

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

Product Code Details

Product Code

OLV

Product Code Name

Standard Polysomnograph With Electroencephalograph

Device Record Status

Public Device Record Key

85e4ae05-f519-467b-949b-4dec8868ffc1

Public Version Date

January 11, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ADVANCED BRAIN MONITORING, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 140