Duns Number:141668116
Device Description: Sunset Healthcare Solutions - Bemis - 800cc Suction Canister - 70/case
Catalog Number
RES023-70
Brand Name
Sunset Healthcare Solutions - Bemis - 800cc Suction Canister
Version/Model Number
RES023-70
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GCX
Product Code Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Public Device Record Key
9c6233bb-349d-4a0a-947a-deefd3f601ea
Public Version Date
January 08, 2021
Public Version Number
7
DI Record Publish Date
September 24, 2016
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 | 160 |
2 | A medical device with a moderate to high risk that requires special controls. | 68 |