Merit Medical® - ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Duns Number:595138793

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More Product Details

Catalog Number

684060/A

Brand Name

Merit Medical®

Version/Model Number

00884450361023

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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)

-

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

455989fb-d09f-405e-9b20-6c59e18e14ed

Public Version Date

December 13, 2021

Public Version Number

2

DI Record Publish Date

August 21, 2020

Additional Identifiers

Package DI Number

10884450361020

Quantity per Package

1

Contains DI Package

00884450361023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"ARGON CRITICAL CARE SYSTEMS SINGAPORE 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. 392