Dustfilter 40pcs Reus.Abso.Flow-i - Contains 2x20 pc of filter without direct marking - Maquet Critical Care AB

Duns Number:632707092

Device Description: Contains 2x20 pc of filter without direct marking

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More Product Details

Catalog Number

-

Brand Name

Dustfilter 40pcs Reus.Abso.Flow-i

Version/Model Number

6880430

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

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

BSF

Product Code Name

Absorber, Carbon-Dioxide

Device Record Status

Public Device Record Key

c74a44c1-8efc-4c73-9a86-014a5c21da54

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MAQUET CRITICAL CARE AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 62
2 A medical device with a moderate to high risk that requires special controls. 131