DEVICE: Dixie EMS Supply (06946430400918)
Device Identifier (DI) Information
Dixie EMS Supply
CP641002+2A+PG
In Commercial Distribution
XIAMEN COMPOWER MEDICAL TECH. CO., LTD
CP641002+2A+PG
In Commercial Distribution
XIAMEN COMPOWER MEDICAL TECH. CO., LTD
The cardiopulmonary resuscitation aid kit comprises of one CPR mask without Oxygen Port, two pieces alcohol pads and one pair PVC glove. This kit is designed for mouth to mask ventilation to health emergency patients requiring cardiopulmonary resuscitator (CPR) rescue techniques of a non-breathing patient. It functions as a barrier to direct expired air from the patient away from the user. It can be used with supplemental oxygen when needed.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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35693 | Cardiopulmonary resuscitation kit, single-use |
A collection of items in a portable case intended for cardiopulmonary resuscitation (e.g., airway tubes, face masks, resuscitator). It is typically placed in a convenient location in public buildings and in emergency medical services (EMS) vehicles for quick access in emergency situations. This is a single-use device.
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FDA Product Code
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No Product Codes |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
2e443688-0c44-4f7d-95b3-5de7b9c671bc
April 03, 2024
3
July 05, 2018
April 03, 2024
3
July 05, 2018
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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16946430400915 | 60 | 06946430400918 | In Commercial Distribution | carton |
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
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No Customer Contact currently defined