Duns Number:216344051
Device Description: The RENASYS Procedure Packs are intended to be used in conjunction with Smith & Nephew NPW The RENASYS Procedure Packs are intended to be used in conjunction with Smith & Nephew NPWT systems. Smith & Nephew NPWT systems are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.
Catalog Number
66020961
Brand Name
Renasys
Version/Model Number
66020961
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K142979,K142979
Product Code
OMP
Product Code Name
Negative Pressure Wound Therapy Powered Suction Pump
Public Device Record Key
4ee5be83-9b78-4642-822e-df6d78c2363b
Public Version Date
November 29, 2021
Public Version Number
4
DI Record Publish Date
September 20, 2019
Package DI Number
30040565127232
Quantity per Package
5
Contains DI Package
00040565127231
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 63 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 126 |
| U | Unclassified | 1 |