944-071 Rinse Solution S4930 for ABL5 - S4930 Rinse Solution 340mL for ABL5, BPH5 - Radiometer Medical ApS

Duns Number:308667539

Device Description: S4930 Rinse Solution 340mL for ABL5, BPH5

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More Product Details

Catalog Number

944-071

Brand Name

944-071 Rinse Solution S4930 for ABL5

Version/Model Number

944-071

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 16, 2020

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

CHL

Product Code Name

Electrode measurement, blood-gases (pco2, po2) and blood ph

Device Record Status

Public Device Record Key

509882bf-723e-4881-99a2-299c20edc10e

Public Version Date

October 22, 2018

Public Version Number

1

DI Record Publish Date

September 21, 2018

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