DEVICE: Pocket Mask, w/O2, SP w/o wipe (Black, CDN) (07045430079700)
Device Identifier (DI) Information
Pocket Mask, w/O2, SP w/o wipe (Black, CDN)
83004120
In Commercial Distribution
83004120
Laerdal Medical AS
83004120
In Commercial Distribution
83004120
Laerdal Medical AS
The Pocket Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult.
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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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 |
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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 Temperature: 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
b78edbd4-447f-4885-8df2-fed908fdef80
December 14, 2021
3
October 20, 2015
December 14, 2021
3
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 |
---|---|---|---|---|---|
07045432068405 | 100 | 07045430079700 | 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