Duns Number:078582655
Device Description: Hydraulic Patient Lift 400 lb. Weight Capacity
Catalog Number
PL400H
Brand Name
Protekt Lift
Version/Model Number
PL400H
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
83b8c249-5a98-440a-bfab-9aec2927e9a2
Public Version Date
May 19, 2022
Public Version Number
1
DI Record Publish Date
May 11, 2022
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 | 20 |
2 | A medical device with a moderate to high risk that requires special controls. | 126 |