Catalog Number

R5100071

Brand Name

Performer HT

Version/Model Number

000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 07, 2018

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K120026

Product Code

LGZ

Product Code Name

Warmer, Thermal, Infusion Fluid

Public Device Record Key

2a2d0566-91fc-4950-9fed-d4699fa3166a

Public Version Date

April 17, 2020

Public Version Number

5

DI Record Publish Date

January 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-