Catalog Number

8130-20

Brand Name

MediByte Electrode Prep Kit

Version/Model Number

8130-20

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

CAT

Product Code Name

Cannula, Nasal, Oxygen

Public Device Record Key

a3ee7ff8-9f4e-4ed0-99e3-befc33371c44

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

November 08, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-