Thermodilution Catheter - Thermodilution Catheter 7.5F - 5 Lumen - ARGON MEDICAL DEVICES, INC.

Duns Number:140727624

Device Description: Thermodilution Catheter 7.5F - 5 Lumen

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More Product Details

Catalog Number

497520

Brand Name

Thermodilution Catheter

Version/Model Number

497520

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 02, 2017

Issuing Agency

In GS1

Product Characteristics

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)

Yes

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 Details

Product Code

DQO

Product Code Name

Catheter, Intravascular, Diagnostic

Device Record Status

Public Device Record Key

9b7887d1-8455-4b61-8283-33a9e1d18449

Public Version Date

June 07, 2019

Public Version Number

3

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

20886333214666

Quantity per Package

5

Contains DI Package

00886333214662

Package Discontinue Date

November 02, 2017

Package Status

Not in Commercial Distribution

Package Type

Box

"ARGON MEDICAL DEVICES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 347
2 A medical device with a moderate to high risk that requires special controls. 1205