Duns Number:249675476
Device Description: The Freedom500 is an AC-powered medical bed with 4 built-in electric DC actuators. The hei The Freedom500 is an AC-powered medical bed with 4 built-in electric DC actuators. The height and surface contours are adjustable.
Catalog Number
FM500
Brand Name
Freedom 500
Version/Model Number
FM500
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 09, 2018
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"
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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
44d17738-65f6-4124-8de1-4ea071cf709c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 22, 2016
Package DI Number
10670482000088
Quantity per Package
1
Contains DI Package
00670482000081
Package Discontinue Date
January 09, 2018
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 |