Anesthesia mask disp, size 3 - Maquet Critical Care AB

Duns Number:632707092

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More Product Details

Catalog Number

-

Brand Name

Anesthesia mask disp, size 3

Version/Model Number

6694262

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 10, 2019

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

BSJ

Product Code Name

Mask, Gas, Anesthetic

Device Record Status

Public Device Record Key

be789ec0-259e-462a-abb9-d5a2b52311f3

Public Version Date

September 11, 2019

Public Version Number

3

DI Record Publish Date

December 10, 2015

Additional Identifiers

Package DI Number

17325710002435

Quantity per Package

20

Contains DI Package

07325710002438

Package Discontinue Date

September 10, 2019

Package Status

Not in Commercial Distribution

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