S8377 REF 944-136 *6 Cleaning solution Met II Solution - S8377 Cleaning MET II Solution membrane bottle , - Radiometer Medical ApS

Duns Number:308667539

Device Description: S8377 Cleaning MET II Solution membrane bottle , 6*100mL for ABL8XX

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More Product Details

Catalog Number

944-136

Brand Name

S8377 REF 944-136 *6 Cleaning solution Met II Solution

Version/Model Number

944-136

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

37942c5c-0aeb-4b7d-8883-e5fa06cf2021

Public Version Date

October 22, 2018

Public Version Number

1

DI Record Publish Date

September 21, 2018

Additional Identifiers

Package DI Number

15700699441369

Quantity per Package

6

Contains DI Package

05700699441362

Package Discontinue Date

-

Package Status

In Commercial Distribution

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