Duns Number:070556204
Device Description: Curaplex Blood Glucose Test Strips 50/BX
Catalog Number
2763-32703
Brand Name
Curaplex
Version/Model Number
2763-32703
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K082965,K082965,K082965
Product Code
CGA
Product Code Name
GLUCOSE OXIDASE, GLUCOSE
Public Device Record Key
c8c63945-bb06-4cf5-809e-ac65c2a466f5
Public Version Date
August 09, 2019
Public Version Number
2
DI Record Publish Date
December 15, 2018
Package DI Number
00812277030044
Quantity per Package
2
Contains DI Package
00812277030037
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 | 471 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 540 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 1 |