Meritrans DTXPlus® - ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Duns Number:595138793

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More Product Details

Catalog Number

682034/B

Brand Name

Meritrans DTXPlus®

Version/Model Number

10884450385163

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

DXN

Product Code Name

System, measurement, blood-pressure, non-invasive

Device Record Status

Public Device Record Key

240a7c21-e4b9-4aaa-8fa3-91c9ff9391f1

Public Version Date

June 16, 2022

Public Version Number

1

DI Record Publish Date

June 08, 2022

Additional Identifiers

Package DI Number

20884450385160

Quantity per Package

10

Contains DI Package

10884450385163

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