Duns Number:966390890
Device Description: Precision Xtra Blood Glucose & Ketone Monitoring System
Catalog Number
98814
Brand Name
Precision Xtra
Version/Model Number
98814
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
K040814,K040814
Product Code
JIN
Product Code Name
NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
Public Device Record Key
d3032351-c151-42f7-8b3f-90b919ab688b
Public Version Date
December 11, 2019
Public Version Number
5
DI Record Publish Date
August 12, 2016
Package DI Number
30093815988145
Quantity per Package
4
Contains DI Package
00093815988144
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 | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |
| 3 | A medical device with high risk that requires premarket approval | 2 |