DEVICE: Rondex CPR Pocket Rescue Mask (Made in USA) model #9120 (06343760091203)
Device Identifier (DI) Information
Rondex CPR Pocket Rescue Mask (Made in USA) model #9120
9120 (packaged in a plastic clamshell case)
Not in Commercial Distribution
9120
RONDEX PRODUCTS, INCORPORATED
9120 (packaged in a plastic clamshell case)
Not in Commercial Distribution
9120
RONDEX PRODUCTS, INCORPORATED
The Rondex CPR Pocket Rescue Mask, Model #9120, is for emergency mouth-to-mask ventilation on a non-breathing adult or child. There is a silicone valve inside the valve housing to help isolate the patient's breath from the rescuer. The mask has a unique design (Design Registered) that even allows rescuers with small hands or rescuers with wet hands a more comfortable means to hold the mask. The mask can be folded down and stored in the plastic clamshell case along with the valve. Made In USA
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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61326 | Cardiopulmonary resuscitation mask, single-use |
A flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS) or as part of first aid kits. This is a single-use device.
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FDA Product Code
[?]Product Code | Product Code Name |
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CBP | Valve, Non-Rebreathing |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K902299 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
dcf99a88-70bf-453d-9f6e-b1cd47b7119d
July 07, 2020
4
November 26, 2016
July 07, 2020
4
November 26, 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
[?]
815-226-0452
request@rondex.com
request@rondex.com