AccessGUDID - DEVICE: Mask ClassicStar Nasal NV, S (04048675250821)

GUDID

Device Identifier (DI) Information

Brand Name: Mask ClassicStar Nasal NV, S
Version or Model: MP01623
Catalog Number:
Company Name: Drägerwerk AG & Co. KGaA

Primary DI Number: 04048675250821
Issuing Agency: GS1
Device Count: 1

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

GMDN Preferred Term Name	GMDN Definition
Rebreathing oxygen face mask	A flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It is typically non-sterile, non-conductive, and is available in a range of sizes. It is made of high-grade resins and/or other materials that produce a soft, flexible mask that will create an airtight seal against the patient's face. The device may include a headstrap and various valves and connectors which may allow for connection to a central vacuum system to enable scavenging of residual (waste) anaesthetic gas from a patient in recovery. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Rebreathing oxygen face mask

A flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It is typically non-sterile, non-conductive, and is available in a range of sizes. It is made of high-grade resins and/or other materials that produce a soft, flexible mask that will create an airtight seal against the patient's face. The device may include a headstrap and various valves and connectors which may allow for connection to a central vacuum system to enable scavenging of residual (waste) anaesthetic gas from a patient in recovery. This is a single-use device.

FDA Product Code

[?]

Product Code	Product Code Name
CBK	Ventilator, Continuous, Facility Use

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: October 24, 2015
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

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

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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DEVICE: Mask ClassicStar Nasal NV, S (04048675250821)