DEVICE: Paediatric Pocket Mask CPR Barrier Device (07045430011557)
Device Identifier (DI) Information
Paediatric Pocket Mask CPR Barrier Device
820050
In Commercial Distribution
820050
Laerdal Medical AS
820050
In Commercial Distribution
820050
Laerdal Medical AS
The Laerdal Paediatric Pocket Mask is a device designed for mouth-to-mask ventilation of a non-breathing child or infant.
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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K023805 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity |
Storage Environment Temperature: between -40 and 50 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
caeac4ff-246f-45d8-86b0-1ce032d6de28
July 06, 2018
3
October 19, 2015
July 06, 2018
3
October 19, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
07045432068474 | 10 | 07045430011557 | 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
[?]
(800)4311055
customerservice@laerdal.com (877) 523-7325
customerservice@laerdal.com
customerservice@laerdal.com (877) 523-7325
customerservice@laerdal.com