Duns Number:207372814
Device Description: Convenient for home, car or workplace, this invalid ring allows you to sit comfortably for Convenient for home, car or workplace, this invalid ring allows you to sit comfortably for long periods of time. Inflation level can be adjusted to maximize comfort and the open center helps distribute weight evenly. Made from heavy duty rubber with a metal air release valve.
Catalog Number
-
Brand Name
MedPro Inflatable Rubber Invalid Ring
Version/Model Number
745-176
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
KIC
Product Code Name
Cushion, Flotation
Public Device Record Key
65b70794-285b-4f0f-a90c-2fd66e1e5a73
Public Version Date
August 21, 2020
Public Version Number
2
DI Record Publish Date
September 26, 2018
Package DI Number
05756599109062
Quantity per Package
5
Contains DI Package
05756596890000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |