DEVICE: Malem (05060049630243)

Device Identifier (DI) Information

Malem
MO3V
In Commercial Distribution

MALEM MEDICAL LIMITED
05060049630243
GS1

1
291490076 *Terms of Use
Malem Personal Continence Trainer (MO3) enuresis alarm (vibrating, green)
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
Incontinence sensor/alarm A battery-powered electronic device intended to provide an audible, visible and/or tactile signal to alert the patient when a small quantity of urine and/or faeces incontinently released is detected by a sensing mechanism (e.g., a sensor pad or detector). It is typically used in the treatment of nocturnal bedwetting (enuresis) in a child or a person with a disability.
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FDA Product Code

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Product Code Product Code Name
KPN Alarm, Conditioned Response Enuresis
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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

a212012e-2140-451b-86e8-2fc7312bef47
March 29, 2018
2
August 31, 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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
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No CLOSE

Customer Contact

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No Customer Contact currently defined
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