Duns Number:080446796
Device Description: Disposable waste collection unit for SOMAVAC Sustained Vacuum System with 100cc total capa Disposable waste collection unit for SOMAVAC Sustained Vacuum System with 100cc total capacity.
Catalog Number
20021
Brand Name
SOMAVAC Waste Collection Unit
Version/Model Number
20021
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K180606,K180606,K180606
Product Code
GCY
Product Code Name
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Public Device Record Key
62e83fe4-2dda-4b02-b268-6b08ba2f76db
Public Version Date
January 08, 2021
Public Version Number
4
DI Record Publish Date
August 23, 2019
Package DI Number
10850004219048
Quantity per Package
5
Contains DI Package
00850004219041
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |