AnsCare SIMO

Primary DI
04719745008221
Brand
AnsCare SIMO
Company
BENQ MATERIALS CORP.
Model
NP-2-4
Device description
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).
Published
2021-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OKONegative Pressure Wound Therapy Non-Powered Suction Apparatus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKONegative Pressure Wound Therapy Non-Powered Suction ApparatusGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193185000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193185000Anscare SIMO Negative Pressure Wound Therapy (NPWT) SystemBenq Materials Corporation2020-05-04OKO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719745008221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719745008221047197450082214719745008221

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system pump, mechanicalA portable device intended to create and control negative pressure in a vacuum-assisted wound closure system during negative pressure wound therapy (NPWT) for the treatment of hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, venous/diabetic/pressure ulcers, surgical wounds, flaps and grafts. It creates a vacuum by non-electric mechanical means (e.g., spring) and is connected to a NPWT system dressing set. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657476292
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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Primary DI, Brand, Model table
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04719745088810DermaAngel Clear Patch IntensiveAP-SA1l1-f2024-07-08
04719745088827DermaAngel Clear Patch IntensiveAP-SA1y1-h2024-07-08
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