Duns Number:070556204
Device Description: Curaplex Blood Glucose Meter
Catalog Number
2761-32701
Brand Name
Curaplex
Version/Model Number
2761-32701
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
-
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
Product Code
NBW
Product Code Name
SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
Public Device Record Key
1b64e155-e311-4b79-a349-4609fec67990
Public Version Date
August 09, 2019
Public Version Number
2
DI Record Publish Date
December 15, 2018
Package DI Number
00812277030020
Quantity per Package
100
Contains DI Package
00812277030013
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 | 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 |