Duns Number:023904428
Device Description: CARD, LOAD RECORD DUAL
Catalog Number
-
Brand Name
McKesson
Version/Model Number
73-DLC250
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
Yes
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
JOJ
Product Code Name
Indicator, Physical/Chemical Sterilization Process
Public Device Record Key
61c0201e-9880-4ffb-8e8d-2ce93dd8c071
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
December 09, 2016
Package DI Number
40612479159783
Quantity per Package
10
Contains DI Package
20612479159772
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 |