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 ID: 00389154000389
• NIH Device Record Key: 0211a33d-e25a-4a88-aa92-7fb6e8440938
• Commercial Distribution Discontinuation: 2017-03-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Rosie SmartMeter
• Version Model Number: AC11
• Catalog Number: 3K-01-16003H
• Company DUNS: 658644174
• Company Name: HMD BIOMEDICAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-841-1109
• Email: info@nurserosie.com
• Phone: 1-800-841-1109
• Email: info@nurserosie.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00389154000389 [Primary]
GS1	00389154000457 [Package]; Package: [63 Units]; Discontinued: 2017-03-13; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113307

FDA Product Code

• LFR: Glucose Dehydrogenase, Glucose

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-09
• Device Publish Date: 2016-09-02

On-Brand Devices [Rosie SmartMeter ]

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