Catalog Number

3847

Brand Name

PremierPro

Version/Model Number

3847

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

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

-

Product Code

DWJ

Product Code Name

System, Thermal Regulating

Public Device Record Key

875759c3-f4e8-417e-bf02-f1a0e47bce65

Public Version Date

July 05, 2021

Public Version Number

2

DI Record Publish Date

April 05, 2019

Package DI Number

10811220031920

Quantity per Package

10

Contains DI Package

00811220031923

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case