SIMAVITA (AUST) PTY LTD

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Alarm, Conditioned Response Enuresis (KPN) (10)

Premarket Exempt

Clear

SIM sensor Moderate - 09342124000377 Catalog Number :

Device Class : 2

Duns Number: 757459958

Premarket Exempt : No

Product Code : KPN

Prescription Use : No

Device Count : 1

SIM sensor Heavy - 09342124000384 Catalog Number :

Device Class : 2

Duns Number: 757459958

Premarket Exempt : No

Product Code : KPN

Prescription Use : No

Device Count : 1

SIM pants XL - 09342124000407 Catalog Number :

Device Class :

Duns Number: 757459958

Premarket Exempt : No

Product Code : KPN

Prescription Use : No

Device Count : 3

SIM pants XXL - 09342124000414 Catalog Number :

Device Class :

Duns Number: 757459958

Premarket Exempt : No

Product Code : KPN

Prescription Use : No

Device Count : 3

SIM assess sensor pad kit - LIGHT - 09342124000445 Catalog Number :

Device Description : SIM assess sensor pad LIGHT kit which contains:- 30 x SIM assess sensor pad LIGH SIM assess sensor pad LIGHT kit which contains:- 30 x SIM assess sensor pad LIGHT- 9 x SIM pants REGULAR

Device Class : 2

Duns Number: 757459958

Premarket Exempt : No

Product Code : KPN

Prescription Use : No

Device Count : 1

SIM assess sensor pad kit - MODERATE - 09342124000452 Catalog Number :

Device Description : SIM assess sensor pad MODERATE kit which contains:- 20 x SIM assess sensor pad M SIM assess sensor pad MODERATE kit which contains:- 20 x SIM assess sensor pad MODERATE- 9 x SIM pants REGULAR

Device Class : 2

Duns Number: 757459958

Premarket Exempt : No

Product Code : KPN

Prescription Use : No

Device Count : 1

SIM assess sensor pad kit - HEAVY - 09342124000469 Catalog Number :

Device Description : SIM assess sensor pad HEAVY kit which contains:- 20 x SIM assess sensor pad HEAV SIM assess sensor pad HEAVY kit which contains:- 20 x SIM assess sensor pad HEAVY- 9 x SIM pants REGULAR

Device Class : 2

Duns Number: 757459958

Premarket Exempt : No

Product Code : KPN

Prescription Use : No

Device Count : 1

SIM assess sensor pad Light - 09342124000476 Catalog Number :

Device Class : 2

Duns Number: 757459958

Premarket Exempt : No

Product Code : KPN

Prescription Use : No

Device Count : 1

SIM assess sensor pad Moderate - 09342124000483 Catalog Number :

Device Class : 2

Duns Number: 757459958

Premarket Exempt : No

Product Code : KPN

Prescription Use : No

Device Count : 1

SIM assess sensor pad Heavy - 09342124000490 Catalog Number :

Device Class : 2

Duns Number: 757459958

Premarket Exempt : No

Product Code : KPN

Prescription Use : No

Device Count : 1

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