Catalog Number

049960401A

Brand Name

Argon Medical Devices, Inc.

Version/Model Number

049960401A

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

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

DRS

Product Code Name

Transducer, Blood-Pressure, Extravascular

Public Device Record Key

6de7efea-c697-4cc4-9cb0-b68f8425c8f7

Public Version Date

January 23, 2019

Public Version Number

3

DI Record Publish Date

September 29, 2017

Package DI Number

20886333223187

Quantity per Package

10

Contains DI Package

00886333223183

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box