Guardian

GUDID 00854950002269

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: 00854950002269
• NIH Device Record Key: ce560219-782d-4c64-8796-2015829c1ae4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guardian
• Version Model Number: TGV65W
• 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	00854950002269 [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

Devices Manufactured by Theos Medical Systems, Inc.

• 00854950002023 - Chummie: 2024-01-12 A electrically-powered electronic device intended to provide an audible, visible and/or tactile signal to alert the patient or a
• 00854950002030 - Chummie: 2024-01-12 A electrically-powered electronic device intended to provide an audible, visible and/or tactile signal to alert the patient or a
• 00854950002047 - Chummie: 2024-01-12 A electrically-powered electronic device intended to provide an audible, visible and/or tactile signal to alert the patient or a
• 00854950002078 - Chummie: 2024-01-12 A electrically-powered electronic device intended to provide an audible, visible and/or tactile signal to alert the patient or a
• 00854950002085 - Chummie: 2024-01-12 A electrically-powered electronic device intended to provide an audible, visible and/or tactile signal to alert the patient or a
• 00854950002153 - Chummie: 2024-01-12 A electrically-powered electronic device intended to provide an audible, visible and/or tactile signal to alert the patient or a
• 00854950002177 - Chummie: 2024-01-12 A electrically-powered electronic device intended to provide an audible, visible and/or tactile signal to alert the patient or a
• 00854950002184 - Chummie: 2024-01-12 A electrically-powered electronic device intended to provide an audible, visible and/or tactile signal to alert the patient or a