DEVICE: Mask nonreb O2Star w tube M/L (04048675382225)

Device Identifier (DI) Information

Mask nonreb O2Star w tube M/L
MP01920
In Commercial Distribution

Drägerwerk AG & Co. KGaA
04048675382225
GS1

50
315578914 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
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No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Non-rebreathing oxygen face mask A non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patient's airway. It typically includes two unidirectional valves, one that closes during inspiration to prevent room air mixing with oxygen in a reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of soft, flexible polymers designed to create an airtight seal against the patient's face. It may include tubing, and various valves and connectors, however other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
KGB Mask, Oxygen, Non-Rebreathing
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

47d92698-d8c5-483b-9dcb-65f07d7f54ff
May 23, 2018
3
October 24, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: 04048675420637 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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+494518820
info@draeger.com
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