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AnsCare SIMO

FDA UDI

Class II (US FDA UDI)

by Benq Materials Corp.

Identity

Trade Name
AnsCare SIMO FDA UDI
Generic Name
Negative-pressure wound therapy system pump, mechanical FDA UDI
Device Name
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). FDA UDI
Model / Reference
NP-2-2 FDA UDI
Description
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). FDA UDI

Identifiers

Primary DI / UDI-DI
04719745008207 FDA UDI
510(k) Number
K193185 FDA UDI
FDA Product Code
OKO FDA UDI
GMDN Term
Negative-pressure wound therapy system pump, mechanical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4683 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Negative-pressure wound therapy system pump, mechanical

AnsCare SIMO by Benq Materials Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Negative-pressure wound therapy system pump, mechanical.

Cleared under the same submission

K193185 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Benq Materials Corp.

Sources (1)

  • FDA UDI ec7ddfab-1235-49c5-a2e5-9605335d84ee 34 fields · synced May 30, 2026