DEVICE: Pocket Mask,SP(Black,IE) (07045430043923)
Device Identifier (DI) Information
Pocket Mask,SP(Black,IE)
82004133
In Commercial Distribution
82004133
Laerdal Medical AS
82004133
In Commercial Distribution
82004133
Laerdal Medical AS
The Pocket Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult, 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? |
---|---|---|---|---|
36066 | Cardiopulmonary resuscitation mask, reusable |
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). This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CBP | Valve, Non-Rebreathing |
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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Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity |
Storage Environment Temperature: between -40 and 52 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
bb3eeac3-1145-493b-82bc-f588a485dfb3
March 29, 2018
2
October 20, 2015
March 29, 2018
2
October 20, 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 |
---|---|---|---|---|---|
07045432068269 | 100 | 07045430043923 | 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