Duns Number:874709348
Device Description: BATH LIFT, ADJUSTABLE RECLINE, BACKREST AUTO RETURNS TO THE UPRIGHT POSITION, WT. LIMIT 30 BATH LIFT, ADJUSTABLE RECLINE, BACKREST AUTO RETURNS TO THE UPRIGHT POSITION, WT. LIMIT 300 LBS.
Catalog Number
-
Brand Name
DALTON BATH LIFT
Version/Model Number
PL303
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
FNG
Product Code Name
Lift, Patient, Ac-Powered
Public Device Record Key
05cab27f-4c78-41ba-87fc-57f7d4e8e96a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 10, 2016
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 |