DEVICE: LSP (00260720011438)

Device Identifier (DI) Information

LSP
L64184
In Commercial Distribution

ALLIED HEALTHCARE PRODUCTS, INC.
00260720011438
GS1

12
099674145 *Terms of Use
CPR Mask with One Way Valve
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Non-rebreathing oxygen face mask A non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patient's airway. It typically includes two unidirectional valves, one that closes during inspiration to prevent room air mixing with oxygen in a reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of soft, flexible polymers designed to create an airtight seal against the patient's face. It may include tubing, and various valves and connectors, however other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
CBP Valve, Non-Rebreathing
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K010191 000
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

c35258bd-43dc-4004-97d4-b81d93b62ba6
July 06, 2018
4
August 25, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: 40260720011436 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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