Duns Number:249675476
Device Description: Medical bed.
Catalog Number
FM500
Brand Name
Freedom 500
Version/Model Number
FM500
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 03, 2021
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
FNL
Product Code Name
Bed, Ac-Powered Adjustable Hospital
Public Device Record Key
757e11d0-9b6b-4b35-93fd-af2680495d4d
Public Version Date
February 08, 2021
Public Version Number
4
DI Record Publish Date
January 10, 2018
Package DI Number
10670482000125
Quantity per Package
1
Contains DI Package
00670482000128
Package Discontinue Date
February 03, 2021
Package Status
Not in Commercial Distribution
Package Type
-
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. | 32 |