Duns Number:070556204
Device Description: Assure Prism Black Kit BASIC w/ Foil Test Strips
Catalog Number
670243-KIT
Brand Name
Curaplex
Version/Model Number
670243-KIT
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
-
Product Code
NBW
Product Code Name
System, test, blood glucose, over the counter
Public Device Record Key
c3239ca3-defd-434b-8f95-ea7f7f85cdcb
Public Version Date
August 16, 2022
Public Version Number
2
DI Record Publish Date
September 30, 2021
Package DI Number
00810094571764
Quantity per Package
30
Contains DI Package
00810071632082
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| 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 |