Catalog Number

3630

Brand Name

PremierPro

Version/Model Number

3630

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"

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

IMD

Product Code Name

Pack, Hot Or Cold, Disposable

Public Device Record Key

0d145606-eb0c-439f-95a6-df6fa2f5c610

Public Version Date

August 12, 2020

Public Version Number

1

DI Record Publish Date

August 04, 2020

Package DI Number

10818566017625

Quantity per Package

24

Contains DI Package

00818566017628

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case