Medisize® - Medisize Blue Small HMEF - Medisize B.V.

Duns Number:407157098

Device Description: Medisize Blue Small HMEF

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More Product Details

Catalog Number

-

Brand Name

Medisize®

Version/Model Number

303 200 000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 12, 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"

Yes

For Single-Use

Yes

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

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Device Record Status

Public Device Record Key

a8c3efe4-75b5-40b6-9287-edc151566b67

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

October 07, 2016

Additional Identifiers

Package DI Number

18717146000021

Quantity per Package

50

Contains DI Package

08717146000024

Package Discontinue Date

May 12, 2020

Package Status

Not in Commercial Distribution

Package Type

Box

"MEDISIZE B.V." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 37
2 A medical device with a moderate to high risk that requires special controls. 26