SIM™ pod

GUDID 09342124000346

SIMAVITA (AUST) PTY LTD

Incontinence sensor/alarm

• Primary Device ID: 09342124000346
• NIH Device Record Key: 9cd232b7-7c46-4a55-9b5e-43a0627bf17b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIM™ pod
• Version Model Number: 6019
• Company DUNS: 757459958
• Company Name: SIMAVITA (AUST) PTY LTD
• Device Count: 1
• DM Exempt: true
• 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09342124000346 [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: 2016-05-04

Devices Manufactured by SIMAVITA (AUST) PTY LTD

• 09342124000162 - SIM pants Regular: 2021-06-21
• 09342124000285 - SIM pod kit: 2021-06-21 ANZ specific SIM pod kit containing: - 1 SIM pod - 1 SIM dock - 1 power supply with ANZ adaptor
• 09342124000292 - SIM pod kit: 2021-06-21 NA specific SIM pod kit containing: - 1 SIM pod - 1 SIM dock - 1 power supply with NA adaptor
• 09342124000308 - SIM pod kit: 2021-06-21 EU specific SIM pod kit containing: - 1 SIM pod - 1 SIM dock - 1 power supply with EU adaptor
• 09342124000315 - SIM sensor LIGHT kit: 2021-06-21 SIM sensor LIGHT kit which contains: - 30 x SIM sensor LIGHT - 9 x SIM pants REGULAR
• 09342124000322 - SIM sensor MODERATE kit: 2021-06-21 SIM sensor MODERATE kit which contains: - 20 x SIM sensor MODERATE; - 6 x SIM pants REGULAR
• 09342124000339 - SIM sensor HEAVY kit: 2021-06-21 SIM sensor HEAVY kit which contains: - 20 x SIM sensor HEAVY; - 6 x SIM pants REGULAR
• 09342124000346 - SIM™ pod: 2021-06-21
• 09342124000346 - SIM™ pod: 2021-06-21