Duns Number:657476292
Device Description: NP-1-1contains 2 piece 10X10cm dressings and 1 SIMO device.Anscare SIMO Negative Pressure 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).
Catalog Number
-
Brand Name
AnsCare SIMO
Version/Model Number
NP-1-1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K193185
Product Code
OKO
Product Code Name
Negative Pressure Wound Therapy Non-Powered Suction Apparatus
Public Device Record Key
9b4c7dc2-a1fb-41bb-8fad-57250c78e4fc
Public Version Date
February 17, 2021
Public Version Number
1
DI Record Publish Date
February 09, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |