ABL80 SC80 - SC80 300/15 BG/Hct, QC3 - Radiometer Medical ApS

Duns Number:308667539

Device Description: SC80 300/15 BG/Hct, QC3

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More Product Details

Catalog Number

945-679

Brand Name

ABL80 SC80

Version/Model Number

945-679

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 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

-

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

CEM

Product Code Name

ELECTRODE, ION SPECIFIC, POTASSIUM

Device Record Status

Public Device Record Key

3fa279c0-a2ce-4079-9d97-6e9668b57ec7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RADIOMETER MEDICAL APS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 124
2 A medical device with a moderate to high risk that requires special controls. 66