Duns Number:874709348
Device Description: HOMECARE BED, FULL-ELECTRIC, WITH RAIL, WT. LIMIT 400 lbs. (Includes patient weight, mattr HOMECARE BED, FULL-ELECTRIC, WITH RAIL, WT. LIMIT 400 lbs. (Includes patient weight, mattress, rails, proper positioning, realignment, transfer and overall care is 400 pounds).
Catalog Number
-
Brand Name
DALTON FULL-ELECTRIC HOMECARE BED
Version/Model Number
BED3300
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
LLI
Product Code Name
Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
Public Device Record Key
5a1c304f-a23b-4a44-b2fc-860ae04a45cb
Public Version Date
October 28, 2020
Public Version Number
1
DI Record Publish Date
October 20, 2020
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 | 66 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 57 |