Thermodilution Catheter and Accessories - BIOPTIMAL INTERNATIONAL PTE. LTD.

Duns Number:595182247

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More Product Details

Catalog Number

21-000117-11

Brand Name

Thermodilution Catheter and Accessories

Version/Model Number

TD1704NDX-ARG(497539)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

-

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

b5bc80df-b44c-47fd-b69a-4366414b4097

Public Version Date

March 10, 2021

Public Version Number

2

DI Record Publish Date

October 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOPTIMAL INTERNATIONAL PTE. LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 188