Mask nonreb O2Star w tube S - Drägerwerk AG & Co. KGaA

Duns Number:315578914

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More Product Details

Catalog Number

-

Brand Name

Mask nonreb O2Star w tube S

Version/Model Number

MP01930

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)

-

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

KGB

Product Code Name

Mask, Oxygen, Non-Rebreathing

Device Record Status

Public Device Record Key

10733b85-7099-4fb4-b1b5-253ba3a70ff2

Public Version Date

May 23, 2018

Public Version Number

3

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DRÄGERWERK AG & CO. KGAA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 220
2 A medical device with a moderate to high risk that requires special controls. 160