Duns Number:070617139
Device Description: StatStrip Xpress2 GLU Meter with Battery and Quick Reference Guide
Catalog Number
56510
Brand Name
Statstrip
Version/Model Number
Xpress2
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K152986,K152986
Product Code
CGA
Product Code Name
GLUCOSE OXIDASE, GLUCOSE
Public Device Record Key
26524c12-9417-428d-b6b2-19792d7af25d
Public Version Date
August 09, 2019
Public Version Number
5
DI Record Publish Date
September 20, 2016
Package DI Number
10385480565100
Quantity per Package
1
Contains DI Package
00385480565103
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 165 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 210 |