PROVIDENCE SEATTLE - CATH LAB TRANSDUCER - Single non-flushing transducer with stopcocks at - ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Duns Number:595138793

Device Description: Single non-flushing transducer with stopcocks at either ends

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More Product Details

Catalog Number

687276

Brand Name

PROVIDENCE SEATTLE - CATH LAB TRANSDUCER

Version/Model Number

687276

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

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

a8a5a0d3-40b2-483c-8178-d55ac0c1fcde

Public Version Date

June 11, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

50886333672764

Quantity per Package

100

Contains DI Package

00886333672769

Package Discontinue Date

-

Package Status

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