Dust filter 20 pcs/pkg - Maquet Critical Care AB

Duns Number:632707092

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More Product Details

Catalog Number

-

Brand Name

Dust filter 20 pcs/pkg

Version/Model Number

6883441

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K192604,K192604

Product Code Details

Product Code

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Device Record Status

Public Device Record Key

f8a8b0a4-b18d-49e4-b0a0-ce6652e47c9b

Public Version Date

September 24, 2020

Public Version Number

1

DI Record Publish Date

September 16, 2020

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