Duns Number:961027315
Device Description: Beverage Glucose Tolerance Test Orange 75gm 10oz 24bt/cs
Catalog Number
BEV-O-075
Brand Name
CARDINAL HEALTH
Version/Model Number
BEV-O-075
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K120247,K120247,K120247
Product Code
MRV
Product Code Name
DRINK, GLUCOSE TOLERANCE
Public Device Record Key
68a3534e-bb8b-44b4-8ab8-e588e10e75ed
Public Version Date
July 17, 2018
Public Version Number
4
DI Record Publish Date
August 15, 2016
Package DI Number
20885380113069
Quantity per Package
10
Contains DI Package
10885380113062
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |