DEVICE: DUAL MASK-PAEDIATRIC MC MALE W/CO2 MONITORING W/FILTER (USA) (05055788754749)
Device Identifier (DI) Information
DUAL MASK-PAEDIATRIC MC MALE W/CO2 MONITORING W/FILTER (USA)
032-12-145U
In Commercial Distribution
FLEXICARE MEDICAL LIMITED
032-12-145U
In Commercial Distribution
FLEXICARE MEDICAL LIMITED
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
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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 |
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CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
812153cb-8902-4db6-bf91-336616a55d02
March 29, 2018
2
October 04, 2016
March 29, 2018
2
October 04, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined