Duns Number:790937150
Catalog Number
-
Brand Name
RC CareChair 850
Version/Model Number
RCCC850B
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
BYN
Product Code Name
Chair, Posture, For Cardiac And Pulmonary Treatment
Public Device Record Key
e3456363-dda8-4c70-a764-df1f9e5b2887
Public Version Date
June 07, 2019
Public Version Number
3
DI Record Publish Date
October 05, 2017
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 | 164 |
2 | A medical device with a moderate to high risk that requires special controls. | 131 |