Catalog Number

BIS/BLV-13

Brand Name

BIS/BLV-13

Version/Model Number

BIS/BLV-13

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 09, 2018

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

K925168

Product Code

DTD

Product Code Name

Pacemaker Lead Adaptor

Public Device Record Key

5fbc5704-8776-4284-a684-7734a73cae69

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

November 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-