Duns Number:658644174
Device Description: Rosie SmartMeter NFC Professional Blood Glucose Monitoring System (Rosie SmartMeter NFC Pr Rosie SmartMeter NFC Professional Blood Glucose Monitoring System (Rosie SmartMeter NFC Professional)
Catalog Number
delete
Brand Name
Rosie SmartMeter
Version/Model Number
AC11-NFC
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
K140150,K140150
Product Code
LFR
Product Code Name
Glucose Dehydrogenase, Glucose
Public Device Record Key
520b3c99-924a-47c5-89fa-ff3e88ab1a81
Public Version Date
August 09, 2019
Public Version Number
4
DI Record Publish Date
September 09, 2016
Package DI Number
389154000518
Quantity per Package
63
Contains DI Package
00389154000501
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 |