Smart

GUDID 00854950002566

A electrically-powered electronic device intended to provide an audible, visible and/or tactile signal to alert the patient or a caregiver 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, and may be used in the home or a healthcare facility.

Theos Medical Systems, Inc.

Incontinence sensor/alarm

• Primary Device ID: 00854950002566
• NIH Device Record Key: 5285b73f-3783-41cb-bad7-f06b6197b651
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smart
• Version Model Number: TSV55W
• Company DUNS: 808427392
• Company Name: Theos Medical Systems, Inc.
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854950002566 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-12
• Device Publish Date: 2024-01-04

On-Brand Devices [Smart]

• 00854950002580: A electrically-powered electronic device intended to provide an audible, visible and/or tactile
• 00854950002566: A electrically-powered electronic device intended to provide an audible, visible and/or tactile