ABL80 SC80 - SC80 25/30 Full, QC3 - Radiometer Medical ApS

Duns Number:308667539

Device Description: SC80 25/30 Full, QC3

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More Product Details

Catalog Number

945-768

Brand Name

ABL80 SC80

Version/Model Number

945-768

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 24, 2022

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

aabcede0-757b-4bad-bc7c-a66ffd03a6df

Public Version Date

September 23, 2022

Public Version Number

4

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