FDA UDI
In Commercial Distribution
🇺🇸 United States
AnsCare SIMO
DI: 04719745008214
·
Model: NP-2-3
·
BENQ MATERIALS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AnsCare SIMO
- Primary DI
- 04719745008214
- Version / Model
- NP-2-3
- Company Name
- BENQ MATERIALS CORP.
- Labeler DUNS
- 657476292
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-09
- Public Version
- 1
- Public Version Date
- 2021-02-17
- Public Version Status
- New
- Public Device Record Key
- 1c335f3d-6a50-4fd7-9c12-e91ac03b4970
Device Description
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 Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OKO | Negative Pressure Wound Therapy Non-Powered Suction Apparatus | General, Plastic Surgery | 878.4683 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60884 | Negative-pressure wound therapy system pump, mechanical | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04719745008214 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193185 | 000 |