Catalog Number

-

Brand Name

Bio Protech

Version/Model Number

RMC80 (Lifelines)

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

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

IKD

Product Code Name

Cable, Electrode

Public Device Record Key

498dae86-de39-40a4-8a08-b8cc2a08318f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 07, 2017

Package DI Number

10817120021368

Quantity per Package

200

Contains DI Package

00817120021361

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case