Duns Number:141668116
Device Description: Sunset HomeFill Rack for Perfecto2 - Black
Catalog Number
RES039-RACKB
Brand Name
Sunset HomeFill Rack for Perfecto2 - Black
Version/Model Number
RES039-RACKB
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
-
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
CCX
Product Code Name
Support, Patient Position
Public Device Record Key
cbd9f7e6-c385-4f1e-8329-545eccccb830
Public Version Date
October 26, 2018
Public Version Number
1
DI Record Publish Date
September 25, 2018
Package DI Number
10848530088764
Quantity per Package
4
Contains DI Package
00848530088767
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |