Catalog Number

-

Brand Name

BV Medical

Version/Model Number

80-800-000-L

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

IRT

Product Code Name

Pad, Heating, Powered

Public Device Record Key

19805555-4ea6-49fb-abc1-63c88d5db01d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 10, 2017

Package DI Number

00845821029669

Quantity per Package

12

Contains DI Package

00845821027313

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-