SIM™ tablet accessories

GUDID 09342124000650

EU

SIMAVITA (AUST) PTY LTD

Incontinence sensor/alarm

• Primary Device ID: 09342124000650
• NIH Device Record Key: a6eea81e-838b-4e8f-a107-4002529776b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIM™ tablet accessories
• Version Model Number: 6035
• 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: 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	09342124000650 [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™ tablet accessories]

• 09342124000667: North America (NA)
• 09342124000650: EU
• 09342124000643: ANZ
• 09342124000605: Global