SAFEDRAW TA4812SDT BLUE - ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Duns Number:595138793

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More Product Details

Catalog Number

689361

Brand Name

SAFEDRAW TA4812SDT BLUE

Version/Model Number

689361

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 10, 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)

-

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

DSK

Product Code Name

Computer, Blood-Pressure

Device Record Status

Public Device Record Key

19405524-685a-4127-b923-367072204328

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 10, 2017

Additional Identifiers

Package DI Number

50886333693615

Quantity per Package

10

Contains DI Package

00886333693610

Package Discontinue Date

April 10, 2017

Package Status

Not in Commercial Distribution

Package Type

Tyvek Bag

"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