SP5555-POLE MOUNTING BRACKET - holder - ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Duns Number:595138793

Device Description: holder

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More Product Details

Catalog Number

682161

Brand Name

SP5555-POLE MOUNTING BRACKET

Version/Model Number

682161

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KRB

Product Code Name

Probe, Thermodilution

Device Record Status

Public Device Record Key

3d4b0234-5ebc-4d30-b492-a80dff8de700

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

50886333621618

Quantity per Package

50

Contains DI Package

00886333621613

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Zip 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