Vaporizer Sevoflurane, MAQUET filling - Maquet Critical Care AB

Duns Number:632707092

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More Product Details

Catalog Number

-

Brand Name

Vaporizer Sevoflurane, MAQUET filling

Version/Model Number

6886601

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

K191027

Product Code Details

Product Code

BSZ

Product Code Name

Gas-Machine, Anesthesia

Device Record Status

Public Device Record Key

cc793b2f-3165-47a4-9cdb-aa7c233c8fcd

Public Version Date

June 03, 2020

Public Version Number

1

DI Record Publish Date

May 26, 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