BENQ MATERIALS CORP.

Address:29, Jianguo E. Rd.,Gueishan Taoyuan,TW

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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

Negative Pressure Wound Therapy Non-Powered Suction Apparatus (OKO) (9) Dressing, Wound, Hydrogel Without Drug And/Or Biologic (NAE) (1)

Premarket Exempt

No Yes

Clear

AnsCare SIMO - 04719745008177 Catalog Number :

Device Description : NP-1-1contains 2 piece 10X10cm dressings and 1 SIMO device.Anscare SIMO Negative NP-1-1contains 2 piece 10X10cm dressings and 1 SIMO device.Anscare SIMO Negative Pressure Wound Therapy (NPWT) System includes a non-sterilized pump and a sterilized dressing. The device provides negative pressure to promote wound healing.Wound exudate is absorbed by the dressing. In addition, the dressing may need to be changed frequently which depends on the wound size, the amount of exudate or the environment. Patients are able to carry the SIMO Pump easily in a pocket or a belt holder (additional accessory).

Device Class : 2

Duns Number: 657476292

Premarket Exempt : No

Product Code : OKO

Prescription Use : Yes

Device Count : 1

AnsCare SIMO - 04719745008184 Catalog Number :

Device Description : NP-1-2 contains 2 piece of 10X20cm dressings and 1 SIMO device.Anscare SIMO Nega NP-1-2 contains 2 piece of 10X20cm dressings and 1 SIMO device.Anscare SIMO Negative Pressure Wound Therapy (NPWT) System includes a non-sterilized pump and a sterilized dressing. The device provides negative pressure to promote wound healing.Wound exudate is absorbed by the dressing. In addition, the dressing may need to be changed frequently which depends on the wound size, the amount of exudate or the environment. Patients are able to carry the SIMO Pump easily in a pocket or a belt holder (additional accessory).

Device Class : 2

Duns Number: 657476292

Premarket Exempt : No

Product Code : OKO

Prescription Use : Yes

Device Count : 1

AnsCare SIMO - 04719745008191 Catalog Number :

Device Description : NP-2-1 contains 3 piece10X10cm dressings.Anscare SIMO Negative Pressure Wound Th NP-2-1 contains 3 piece10X10cm dressings.Anscare SIMO Negative Pressure Wound Therapy (NPWT) System includes a non-sterilized pump and a sterilized dressing. The device provides negative pressure to promote wound healing.Wound exudate is absorbed by the dressing. In addition, the dressing may need to be changed frequently which depends on the wound size, the amount of exudate or the environment. Patients are able to carry the SIMO Pump easily in a pocket or a belt holder (additional accessory).

Device Class : 2

Duns Number: 657476292

Premarket Exempt : No

Product Code : OKO

Prescription Use : Yes

Device Count : 1

AnsCare SIMO - 04719745008207 Catalog Number :

Device Description : NP-2-2 contains 3 piece 10X20cm dressings.Anscare SIMO Negative Pressure Wound T NP-2-2 contains 3 piece 10X20cm dressings.Anscare SIMO Negative Pressure Wound Therapy (NPWT) System includes a non-sterilized pump and a sterilized dressing. The device provides negative pressure to promote wound healing.Wound exudate is absorbed by the dressing. In addition, the dressing may need to be changed frequently which depends on the wound size, the amount of exudate or the environment. Patients are able to carry the SIMO Pump easily in a pocket or a belt holder (additional accessory).

Device Class : 2

Duns Number: 657476292

Premarket Exempt : No

Product Code : OKO

Prescription Use : Yes

Device Count : 1

AnsCare SIMO - 04719745008214 Catalog Number :

Device Description : NP-2-3 contains 3 piece 5X8cm dressings.Anscare SIMO Negative Pressure Wound The NP-2-3 contains 3 piece 5X8cm dressings.Anscare SIMO Negative Pressure Wound Therapy (NPWT) System includes a non-sterilized pump and a sterilized dressing. The device provides negative pressure to promote wound healing.Wound exudate is absorbed by the dressing. In addition, the dressing may need to be changed frequently which depends on the wound size, the amount of exudate or the environment. Patients are able to carry the SIMO Pump easily in a pocket or a belt holder (additional accessory).

Device Class : 2

Duns Number: 657476292

Premarket Exempt : No

Product Code : OKO

Prescription Use : Yes

Device Count : 1

AnsCare SIMO - 04719745008221 Catalog Number :

Device Description : NP-2-4 contains 3 piece 10X15cm dressings.Anscare SIMO Negative Pressure Wound T NP-2-4 contains 3 piece 10X15cm dressings.Anscare SIMO Negative Pressure Wound Therapy (NPWT) System includes a non-sterilized pump and a sterilized dressing. The device provides negative pressure to promote wound healing.Wound exudate is absorbed by the dressing. In addition, the dressing may need to be changed frequently which depends on the wound size, the amount of exudate or the environment. Patients are able to carry the SIMO Pump easily in a pocket or a belt holder (additional accessory).

Device Class : 2

Duns Number: 657476292

Premarket Exempt : No

Product Code : OKO

Prescription Use : Yes

Device Count : 1

Anscare Hydrocolloid Dressing(Sterile) - 04719745008238 Catalog Number :

Device Description : Anscare Hydrocolloid Dressings(Sterile) are hydrophilic, occlusive dressings. Th Anscare Hydrocolloid Dressings(Sterile) are hydrophilic, occlusive dressings. The flexible outer layer helps isolate the wound against bacterial and other external contamination while the dressing remains intact without leakage. The inner layer maintains a moist wound environment while absorbing excess wound exudate to prevent fluid pooling.

Device Class : 1

Duns Number: 657476292

Premarket Exempt : Yes

Product Code : NAE

Prescription Use : Yes

Device Count : 1

AnsCare SIMO - 04719745008252 Catalog Number :

Device Description : NP-1-3 contains 2 piece 5X8cm dressings and 1 SIMO device.Anscare SIMO Negative NP-1-3 contains 2 piece 5X8cm dressings and 1 SIMO device.Anscare SIMO Negative Pressure Wound Therapy (NPWT) System includes a non-sterilized pump and a sterilized dressing. The device provides negative pressure to promote wound healing.Wound exudate is absorbed by the dressing. In addition, the dressing may need to be changed frequently which depends on the wound size, the amount of exudate or the environment. Patients are able to carry the SIMO Pump easily in a pocket or a belt holder (additional accessory).

Device Class : 2

Duns Number: 657476292

Premarket Exempt : No

Product Code : OKO

Prescription Use : Yes

Device Count : 1

AnsCare SIMO - 04719745008269 Catalog Number :

Device Description : NP-1-4 contains 2 piece 10X15cm dressings and 1 SIMO device.Anscare SIMO Negativ NP-1-4 contains 2 piece 10X15cm dressings and 1 SIMO device.Anscare SIMO Negative Pressure Wound Therapy (NPWT) System includes a non-sterilized pump and a sterilized dressing. The device provides negative pressure to promote wound healing.Wound exudate is absorbed by the dressing. In addition, the dressing may need to be changed frequently which depends on the wound size, the amount of exudate or the environment. Patients are able to carry the SIMO Pump easily in a pocket or a belt holder (additional accessory).

Device Class : 2

Duns Number: 657476292

Premarket Exempt : No

Product Code : OKO

Prescription Use : Yes

Device Count : 1

AnsCare SIMO - 04719745008276 Catalog Number :

Device Description : NP-3-1 contains 2 piece 10X10cm dressings and 1 SIMO device with holder.Anscare NP-3-1 contains 2 piece 10X10cm dressings and 1 SIMO device with holder.Anscare SIMO Negative Pressure Wound Therapy (NPWT) System includes a non-sterilized pump and a sterilized dressing. The device provides negative pressure to promote wound healing.Wound exudate is absorbed by the dressing. In addition, the dressing may need to be changed frequently which depends on the wound size, the amount of exudate or the environment. Patients are able to carry the SIMO Pump easily in a pocket or a belt holder (additional accessory).

Device Class : 2

Duns Number: 657476292

Premarket Exempt : No

Product Code : OKO

Prescription Use : Yes

Device Count : 1

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