Duns Number:023904428
Device Description: Heavy Duty Patient Lift Battery Powered Digital scale
Catalog Number
-
Brand Name
McKesson
Version/Model Number
146-13046-HD
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRW
Product Code Name
Scale, Patient
Public Device Record Key
a95c94ca-4cb4-4c1e-9877-62d0ac0fcbfe
Public Version Date
December 10, 2018
Public Version Number
1
DI Record Publish Date
November 09, 2018
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 | 870 |
2 | A medical device with a moderate to high risk that requires special controls. | 422 |
U | Unclassified | 44 |