Malem

GUDID 05060049630373

Malem Bluetooth (MO25) enuresis alarm

MALEM MEDICAL LIMITED

Incontinence sensor/alarm

• Primary Device ID: 05060049630373
• NIH Device Record Key: 527ed746-dde5-44cd-a5b2-fec4ad9ff088
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Malem
• Version Model Number: MO25
• Company DUNS: 291490076
• Company Name: MALEM MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060049630373 [Primary]

FDA Product Code

• KPN: Alarm, Conditioned Response Enuresis

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-01-08
• Device Publish Date: 2016-08-31

On-Brand Devices [Malem]

• 05060049630373: Malem Bluetooth (MO25) enuresis alarm
• 05060049630366: Malem Deluxe (MO24) enuresis alarm
• 05060049630304: Malem Ultimate Selectable (MO4S) enuresis alarm (camouflage)
• 05060049630298: Malem Ultimate Selectable (MO4S) enuresis alarm (magenta)
• 05060049630281: Malem Ultimate 1+ Record (MO5) enuresis alarm (blue)
• 05060049630274: Malem Ultimate (MO4) enuresis alarm (sound 3, purple)
• 05060049630267: Malem Ultimate (MO4) enuresis alarm (sound 2, blue)
• 05060049630250: Malem Ultimate (MO4) enuresis alarm (sound 1, pink)
• 05060049630243: Malem Personal Continence Trainer (MO3) enuresis alarm (vibrating, green)
• 05060049630236: Malem Audio (MO3) 8-tone enuresis alarm (camouflage)
• 05060049630229: Malem Audio (MO3) enuresis alarm (sound 3, orange)
• 05060049630212: Malem Audio (MO3) enuresis alarm (sound 2, green)
• 05060049630205: Malem Audio (MO3) 8-tone enuresis alarm (yellow)
• 05060049630199: Queen's Square Bladder Stimulator (PC9)
• 05060049630182: Malem Ultimate Multi-Choice (MO17) enuresis alarm
• 05060049630168: Malem Universal Wireless (MO15) enuresis alarm
• 05060049630151: Malem Wireless (MO12) enuresis alarm
• 05060049630144: Queen's Square Bladder Stimulator - Selectable (PC9S)
• 05060049630120: Malem Ultimate Selectable (MO4S) enuresis alarm (royal blue)
• 05060049630076: Malem Wireless (MO7) enuresis alarm
• 05060049630069: Malem Bed-Side (MO6) enuresis alarm
• 05060049630052: Malem Ultimate 1+ Record (MO5) enuresis alarm (red)
• 05060049630045: Malem Ultimate (MO4) enuresis alarm (8-tone, gold)
• 05060049630038: Malem Audio (MO3) enuresis alarm (sound 1, red)