Duns Number:007941230
Device Description: Commode Folding Welded Steel Frame Plastic Snap-on Seat Height Adjusts From 17 Inches To 2 Commode Folding Welded Steel Frame Plastic Snap-on Seat Height Adjusts From 17 Inches To 23 Inches In 1 Inch Increments 14-Inch Seat Width Includes Pail With Cover And Splash Shield 300-Pound Evenly Distributed Weight Capacity Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
COMM7001
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"
Yes
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
INN
Product Code Name
CHAIR, ADJUSTABLE, MECHANICAL
Public Device Record Key
f933da67-3587-4aa8-87a6-ad61e5b818d0
Public Version Date
October 28, 2020
Public Version Number
1
DI Record Publish Date
October 20, 2020
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |