Duns Number:249675476
Device Description: AC-powered hospital bed with four built-in electric DC motors and remote controls that is AC-powered hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes. It can be operated by the patient or the caregiver to adjust the height and surface contour of the bed. The bed includes movable and latch able siderails.
Catalog Number
FL23SE
Brand Name
Florence bed
Version/Model Number
FL23SE ERGO
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 08, 2017
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"
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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
645e4294-7ac3-4dc1-8232-0dd74cfc81c1
Public Version Date
September 03, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
20670482000054
Quantity per Package
2
Contains DI Package
00670482000050
Package Discontinue Date
November 08, 2017
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 |