Duns Number:355804758
Device Description: Medical Bed - CITADEL PLUS - USA
Catalog Number
-
Brand Name
Citadel Plus
Version/Model Number
FX811B2B3AMABA
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FNL
Product Code Name
BED, AC-POWERED ADJUSTABLE HOSPITAL
Public Device Record Key
f26506e7-6e96-4afe-8f18-3e94c1d3f28a
Public Version Date
September 19, 2022
Public Version Number
1
DI Record Publish Date
September 10, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 420 |
2 | A medical device with a moderate to high risk that requires special controls. | 840 |