Rosie SmartMeter 3K-01-16003H

GUDID 00389154000389

Rosie SmartMeter Blood Glucose Monitoring System

HMD BIOMEDICAL INC.

Glucose monitoring system IVD, point-of-care
Primary Device ID00389154000389
NIH Device Record Key0211a33d-e25a-4a88-aa92-7fb6e8440938
Commercial Distribution Discontinuation2017-03-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameRosie SmartMeter
Version Model NumberAC11
Catalog Number3K-01-16003H
Company DUNS658644174
Company NameHMD BIOMEDICAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-841-1109
Emailinfo@nurserosie.com
Phone1-800-841-1109
Emailinfo@nurserosie.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100389154000389 [Primary]
GS100389154000457 [Package]
Package: [63 Units]
Discontinued: 2017-03-13
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFRGlucose Dehydrogenase, Glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-08-09
Device Publish Date2016-09-02

On-Brand Devices [Rosie SmartMeter ]

00389154000501Rosie SmartMeter NFC Professional Blood Glucose Monitoring System (Rosie SmartMeter NFC Professi
00389154000389Rosie SmartMeter Blood Glucose Monitoring System

Trademark Results [Rosie SmartMeter]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ROSIE SMARTMETER
ROSIE SMARTMETER
87122475 5165226 Live/Registered
Southern Life Systems, Inc.
2016-08-01
ROSIE SMARTMETER
ROSIE SMARTMETER
85688605 not registered Dead/Abandoned
Southern Life Systems, Inc.
2012-07-27

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