Duns Number:023904428
Device Description: Patient Lift Sling Full body w/ commode opening Large Mesh
Catalog Number
-
Brand Name
McKesson
Version/Model Number
146-13221L
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
FSA
Product Code Name
Lift, Patient, Non-Ac-Powered
Public Device Record Key
92115167-7cd2-4794-b2ad-249204594a39
Public Version Date
December 10, 2018
Public Version Number
1
DI Record Publish Date
November 09, 2018
Package DI Number
00612479222458
Quantity per Package
12
Contains DI Package
00612479222441
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |