AnsCare SIMO

GUDID 04719745008290

NP-3-3 contains 2 piece 5X8cm 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).

BENQ MATERIALS CORP.

Negative-pressure wound therapy system pump, mechanical Negative-pressure wound therapy system pump, mechanical Negative-pressure wound therapy system pump, mechanical Negative-pressure wound therapy system pump, mechanical Negative-pressure wound therapy system pump, mechanical Negative-pressure wound therapy system pump, mechanical Negative-pressure wound therapy system pump, mechanical Negative-pressure wound therapy system pump, mechanical Negative-pressure wound therapy system pump, mechanical Negative-pressure wound therapy system pump, mechanical Negative-pressure wound therapy system pump, mechanical Negative-pressure wound therapy system pump, mechanical Negative-pressure wound therapy system pump, mechanical Negative-pressure wound therapy system pump, mechanical Negative-pressure wound therapy system pump, mechanical

• Primary Device ID: 04719745008290
• NIH Device Record Key: df436957-a331-444a-8e03-d0b7c8f04200
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AnsCare SIMO
• Version Model Number: NP-3-3
• Company DUNS: 657476292
• Company Name: BENQ MATERIALS CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719745008290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193185

FDA Product Code

• OKO: Negative Pressure Wound Therapy Non-Powered Suction Apparatus

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-17
• Device Publish Date: 2021-02-09

On-Brand Devices [AnsCare SIMO]

• 04719745008306: NP-3-4 contains 2 piece10X15cm dressings and 1 SIMO device with holer. Anscare SIMO Negative Pre
• 04719745008290: NP-3-3 contains 2 piece 5X8cm dressings and 1 SIMO device with holder. Anscare SIMO Negative Pre
• 04719745008283: NP-3-2 contains 2 piece 10X20cm dressings and 1 SIMO device with holder. Anscare SIMO Negative P
• 04719745008276: NP-3-1 contains 2 piece 10X10cm dressings and 1 SIMO device with holder. Anscare SIMO Negative P
• 04719745008269: NP-1-4 contains 2 piece 10X15cm dressings and 1 SIMO device. Anscare SIMO Negative Pressure Woun
• 04719745008252: NP-1-3 contains 2 piece 5X8cm dressings and 1 SIMO device. Anscare SIMO Negative Pressure Wound
• 04719745008221: NP-2-4 contains 3 piece 10X15cm dressings. Anscare SIMO Negative Pressure Wound Therapy (NPWT) S
• 04719745008214: NP-2-3 contains 3 piece 5X8cm dressings. Anscare SIMO Negative Pressure Wound Therapy (NPWT) Sys
• 04719745008207: NP-2-2 contains 3 piece 10X20cm dressings. Anscare SIMO Negative Pressure Wound Therapy (NPWT) S
• 04719745008191: NP-2-1 contains 3 piece10X10cm dressings. Anscare SIMO Negative Pressure Wound Therapy (NPWT) Sy
• 04719745008184: NP-1-2 contains 2 piece of 10X20cm dressings and 1 SIMO device. Anscare SIMO Negative Pressure W
• 04719745008177: NP-1-1contains 2 piece 10X10cm dressings and 1 SIMO device. Anscare SIMO Negative Pressure Wound