Catalog Number

3835

Brand Name

PremierPro

Version/Model Number

3835

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)

Yes

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

90d50217-039c-46e2-9e79-edc5c7a4631a

Public Version Date

July 05, 2021

Public Version Number

2

DI Record Publish Date

May 04, 2020

Package DI Number

10811220031852

Quantity per Package

10

Contains DI Package

00811220031855

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case