AccessGUDID - DEVICE: DUAL MASK-PAEDIATRIC MC MALE W/CO2 MONITORING W/FILTER (USA) (05055788754749)

GUDID

Device Identifier (DI) Information

Brand Name: DUAL MASK-PAEDIATRIC MC MALE W/CO2 MONITORING W/FILTER (USA)
Version or Model: 032-12-145U
Catalog Number:
Company Name: FLEXICARE MEDICAL LIMITED

Primary DI Number: 05055788754749
Issuing Agency: GS1
Device Count: 1

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	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):	Yes
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
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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 04, 2016
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: DUAL MASK-PAEDIATRIC MC MALE W/CO2 MONITORING W/FILTER (USA) (05055788754749)