Catalog Number

-

Brand Name

3.6V Battery

Version/Model Number

Bobbin

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K063126,K063126

Product Code

LGZ

Product Code Name

Warmer, Thermal, Infusion Fluid

Public Device Record Key

7079739f-0f6c-44ed-b857-f9d7bc484ec1

Public Version Date

September 12, 2018

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

08809220581021

Quantity per Package

8

Contains DI Package

08809220581014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton