Duns Number:387209518
Device Description: The Exsudex® Disposable Canister, commercially labelled as NewERA Disposable Canister, has The Exsudex® Disposable Canister, commercially labelled as NewERA Disposable Canister, has the following features and is only to be used together with the NewERA I wound drainage system:- Canister capacity 900 cc;- Bacterial filter;- Fixed non-sterile suction tube with clamb and connector- Dissolving sachet solidifying agent
Catalog Number
16670-NEWERA
Brand Name
Exsudex disposable canister
Version/Model Number
NewERA I disposable canister with tube
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 09, 2018
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
-
Product Code
GCY
Product Code Name
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Public Device Record Key
68ab4ec3-a772-4b8f-92a7-2f7af8fbb729
Public Version Date
January 08, 2021
Public Version Number
7
DI Record Publish Date
February 07, 2018
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 | 9 |