Duns Number:023904428
Device Description: SOLUTION, GLUT 2.6% 14DAY QT
Catalog Number
-
Brand Name
McKesson
Version/Model Number
339
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K930284,K930284
Product Code
MED
Product Code Name
Sterilant, Medical Devices
Public Device Record Key
44a0e8c0-ca90-4e4e-b983-0194f299b9b0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 09, 2016
Package DI Number
40612479204391
Quantity per Package
16
Contains DI Package
10612479204383
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 |