Duns Number:070617139
Device Description: StatStrip StatSensor Remanufactured Wireless Carrying Case for Meter and Supplies v1.0
Catalog Number
54422
Brand Name
StatSensor/StatStrip
Version/Model Number
1.0
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
K150281,K150281
Product Code
CGA
Product Code Name
GLUCOSE OXIDASE, GLUCOSE
Public Device Record Key
06ff9df3-faff-434c-a89d-5d1e9f320b74
Public Version Date
August 09, 2019
Public Version Number
5
DI Record Publish Date
September 20, 2016
Package DI Number
10385480544228
Quantity per Package
1
Contains DI Package
00385480544221
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 |