Catalog Number

-

Brand Name

P-2147

Version/Model Number

P-2147

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K132202

Product Code

LGZ

Product Code Name

Warmer, Thermal, Infusion Fluid

Public Device Record Key

08e71f19-22fe-48de-984d-2d03f6598f3d

Public Version Date

February 10, 2021

Public Version Number

2

DI Record Publish Date

August 21, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-