Catalog Number

-

Brand Name

Cramer Decker Medical

Version/Model Number

AREG5415

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CAN

Product Code Name

Regulator, Pressure, Gas Cylinder

Public Device Record Key

3b5c2a1a-d878-4893-b627-695886589e29

Public Version Date

February 08, 2022

Public Version Number

1

DI Record Publish Date

January 31, 2022

Package DI Number

10816505020699

Quantity per Package

20

Contains DI Package

00816505020692

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-