SIM pod kit

GUDID 09342124000292

NA specific SIM pod kit containing: - 1 SIM pod - 1 SIM dock - 1 power supply with NA adaptor

SIMAVITA (AUST) PTY LTD

Incontinence sensor/alarm

• Primary Device ID: 09342124000292
• NIH Device Record Key: 4aae457f-ada3-4a23-a6f5-317eeaa6ea0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIM pod kit
• Version Model Number: 6010
• 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	09342124000292 [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: 2016-07-13

On-Brand Devices [SIM pod kit]

• 09342124000582: Global SIM™ pod kit containing: - 1 SIM pod - 1 SIM dock - 1 power supply with ANZ adaptor, NA
• 09342124000308: EU specific SIM pod kit containing: - 1 SIM pod - 1 SIM dock - 1 power supply with EU adaptor
• 09342124000292: NA specific SIM pod kit containing: - 1 SIM pod - 1 SIM dock - 1 power supply with NA adaptor
• 09342124000285: ANZ specific SIM pod kit containing: - 1 SIM pod - 1 SIM dock - 1 power supply with ANZ adaptor