D8088+D8089 Crea membrane A+B - D8088+D8089 Crea membrane box A+B, with 2xA and - Radiometer Medical ApS

Duns Number:308667539

Device Description: D8088+D8089 Crea membrane box A+B, with 2xA and 2xB membrane units, for ABL8XX

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More Product Details

Catalog Number

942-073

Brand Name

D8088+D8089 Crea membrane A+B

Version/Model Number

942-073

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)

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

b4fa3529-cf50-4d5b-ba15-05bb4a1c1f15

Public Version Date

November 27, 2020

Public Version Number

3

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