Bio-Logic Algo Supplies - Bio-Logic Algo Supplies kit containing - NATUS MEDICAL INCORPORATED

Duns Number:962519208

Device Description: Bio-Logic Algo Supplies kit containing Flexicouplers and JellyTabs intended to be used wit Bio-Logic Algo Supplies kit containing Flexicouplers and JellyTabs intended to be used with Natus hearing screeners.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

011445

Brand Name

Bio-Logic Algo Supplies

Version/Model Number

011445

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

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

-

Product Code Details

Product Code

GWJ

Product Code Name

Stimulator, Auditory, Evoked Response

Device Record Status

Public Device Record Key

983cd1ce-7080-45cb-a3b9-f02b69739e22

Public Version Date

January 14, 2019

Public Version Number

1

DI Record Publish Date

December 13, 2018

Additional Identifiers

Package DI Number

00382830054485

Quantity per Package

4

Contains DI Package

00382830001885

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"NATUS MEDICAL INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 302
3 A medical device with high risk that requires premarket approval 5