SIM pod kit

Basic Information

• Brand Name: SIM pod kit
• Primary DI: 09342124000582
• Version / Model: 6010
• Company Name: SIMAVITA (AUST) PTY LTD
• Labeler DUNS: 757459958
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-14
• Public Version: 5
• Public Version Date: 2021-06-21
• Public Version Status: Update
• Public Device Record Key: 61ff4e62-74e4-40f6-9566-5176f88fecfd

Device Description

Global SIM™ pod kit containing: - 1 SIM pod - 1 SIM dock - 1 power supply with ANZ adaptor, NA adaptor and EU adaptor

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPN	Alarm, Conditioned Response Enuresis	Gastroenterology, Urology	876.2040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11588	Incontinence sensor/alarm	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09342124000582	GS1

Premarket Submissions

Submission Number	Supplement Number
K130951	000