FDA.reportPublic FDA data

SIM assess sensor pad kit - LIGHT

Primary DI
09342124000445
Brand
SIM assess sensor pad kit - LIGHT
Company
SIMAVITA (AUST) PTY LTD
Model
6021
Device description
SIM assess sensor pad LIGHT kit which contains:- 30 x SIM assess sensor pad LIGHT- 9 x SIM pants REGULAR
Published
2016-08-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KPNAlarm, Conditioned Response Enuresis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPNAlarm, Conditioned Response EnuresisGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130951000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130951000SIMSimavita Pty Limited2013-08-22KPN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09342124000445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09342124000445093421240004459342124000445

GMDN Terms#

Term, Definition table
TermDefinition
Incontinence sensor/alarmA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
757459958
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09342124000179SIM pants Regular13032016-06-03
09342124000407SIM pants XL13052016-06-03
09342124000414SIM pants XXL13072016-06-03
09342124000162SIM pants Regular13032016-06-03
09342124000285SIM pod kit60102016-07-13
09342124000292SIM pod kit60102016-07-13
09342124000308SIM pod kit60102016-07-13
09342124000315SIM sensor LIGHT kit60152016-07-22
09342124000322SIM sensor MODERATE kit60162016-07-22
09342124000339SIM sensor HEAVY kit60172016-07-22
09342124000346SIM™ pod60192016-05-04
09342124000353SIM™ dock60202016-05-04
09342124000360SIM sensor Light60082016-07-13
09342124000377SIM sensor Moderate60092016-07-13
09342124000384SIM sensor Heavy60172016-07-13
09342124000421SIM pants XL13052016-06-03
09342124000391SIM pants XXL13072016-06-03
09342124000452SIM assess sensor pad kit - MODERATE60222016-08-16
09342124000469SIM assess sensor pad kit - HEAVY60232016-08-16
09342124000476SIM assess sensor pad Light60242016-08-16

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