FDA UDI
In Commercial Distribution
🇺🇸 United States
SIM sensor HEAVY kit
DI: 09342124000339
·
Model: 6017
·
SIMAVITA (AUST) PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SIM sensor HEAVY kit
- Primary DI
- 09342124000339
- Version / Model
- 6017
- Company Name
- SIMAVITA (AUST) PTY LTD
- Labeler DUNS
- 757459958
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-22
- Public Version
- 5
- Public Version Date
- 2021-06-21
- Public Version Status
- Update
- Public Device Record Key
- 1ccb1cfc-9edb-4280-8930-58558f34d8c4
Device Description
SIM sensor HEAVY kit which contains: - 20 x SIM sensor HEAVY; - 6 x SIM pants REGULAR
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 | 09342124000339 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130951 | 000 |