Duns Number:752905877
Device Description: Electric Treatment chair for use in dialysis, day surgery and oncology applications. The c Electric Treatment chair for use in dialysis, day surgery and oncology applications. The chair is intended for patients with weight not exceeding 660 lbs (300kg)
Catalog Number
-
Brand Name
Fresenius Medical Care
Version/Model Number
T688B
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
INO
Product Code Name
Chair, Positioning, Electric
Public Device Record Key
c269d0d7-0314-45b9-8517-7ad3b1e03b1d
Public Version Date
September 27, 2022
Public Version Number
2
DI Record Publish Date
June 23, 2022
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 4 |