Duns Number:216344051
Device Description: Renasys EZPLUS / Max 800ml S-Canister with Soldifier (Non Sterile)
Catalog Number
66020912
Brand Name
Renasys
Version/Model Number
66020912
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
K142979,K142979
Product Code
OMP
Product Code Name
Negative Pressure Wound Therapy Powered Suction Pump
Public Device Record Key
7bd2df10-f25c-4462-9960-1bcb7518c1a6
Public Version Date
June 22, 2021
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
30040565127263
Quantity per Package
10
Contains DI Package
00040565127262
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 |