Duns Number:023904428
Device Description: Personal Protection Kit 1 day
Catalog Number
-
Brand Name
McKesson
Version/Model Number
59820
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
PXC
Product Code Name
Personal Protection Kit
Public Device Record Key
c3b13ae2-7b4e-42da-8413-1f0526d1d27e
Public Version Date
February 11, 2022
Public Version Number
1
DI Record Publish Date
February 03, 2022
Package DI Number
00612479259133
Quantity per Package
30
Contains DI Package
00612479259126
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 |