Duns Number:658644174
Device Description: Rosie SmartMeter Blood Glucose Monitoring System
Catalog Number
3K-01-16003H
Brand Name
Rosie SmartMeter
Version/Model Number
AC11
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 13, 2017
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
K113307,K113307
Product Code
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
0211a33d-e25a-4a88-aa92-7fb6e8440938
Public Version Date
August 09, 2019
Public Version Number
4
DI Record Publish Date
September 02, 2016
Package DI Number
00389154000457
Quantity per Package
63
Contains DI Package
00389154000389
Package Discontinue Date
March 13, 2017
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |