SIM™ kit

GUDID 09342124000629

SIM™ kit (EU) that contains: - SIM™ pod kit; - SIM™ tablet; - SIM™ tablet accessories;

SIMAVITA (AUST) PTY LTD

Incontinence sensor/alarm

• Primary Device ID: 09342124000629
• NIH Device Record Key: 5e1f7c4d-2702-48e9-9689-ed903392bb75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIM™ kit
• Version Model Number: 6033
• Company DUNS: 757459958
• Company Name: SIMAVITA (AUST) PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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	09342124000629 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130951

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: 5
• Public Version Date: 2021-06-21
• Device Publish Date: 2016-11-14

On-Brand Devices [SIM™ kit]

• 09342124000636: SIM™ kit (NA - North America) that contains: - SIM™ pod kit; - SIM™ tablet; - SIM™ table
• 09342124000629: SIM™ kit (EU) that contains: - SIM™ pod kit; - SIM™ tablet; - SIM™ tablet accessories
• 09342124000612: SIM™ kit (ANZ) that contains: - SIM™ pod kit; - SIM™ tablet; - SIM™ tablet accessories
• 09342124000568: SIM™ kit (Global) that contains: - SIM™ pod kit; - SIM™ tablet; - SIM™ tablet accessorie