Catalog Number

-

Brand Name

Bio Protech

Version/Model Number

BH5026P (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

GXZ

Product Code Name

Electrode, Needle

Public Device Record Key

2a0ed693-c072-4cd7-bf9f-dda4f60286d4

Public Version Date

June 11, 2018

Public Version Number

3

DI Record Publish Date

August 09, 2017

Package DI Number

20817120021037

Quantity per Package

20

Contains DI Package

10817120021030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case