SIM pants XL

Primary DI
09342124000421
Brand
SIM pants XL
Company
SIMAVITA (AUST) PTY LTD
Model
1305
Published
2016-06-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
09342124000421PackageGS130In Commercial Distribution
09342124000407PrimaryGS10
09342124000186Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09342124000421093421240004219342124000421
09342124000407093421240004079342124000407
09342124000186093421240001869342124000186

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
3
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
09342124000346SIMâ„¢ pod60192016-05-04
09342124000353SIMâ„¢ dock60202016-05-04
09342124000360SIM sensor Light60082016-07-13
09342124000377SIM sensor Moderate60092016-07-13
09342124000384SIM sensor Heavy60172016-07-13
09342124000391SIM pants XXL13072016-06-03
09342124000445SIM assess sensor pad kit - LIGHT60212016-08-16
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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