Rosie SmartMeter Glucose Control Solutions 3C-01-160033

GUDID 00868665000069

Rosie SmartMeter glucose control solution

HMD BIOMEDICAL INC.

Glucose IVD, control

• Primary Device ID: 00868665000069
• NIH Device Record Key: ce1c775f-44f6-41c5-a2af-f0d2ba9b03d8
• Commercial Distribution Discontinuation: 2017-01-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Rosie SmartMeter Glucose Control Solutions
• Version Model Number: 3C-01-160033
• Catalog Number: 3C-01-160033
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00389154000532 [Package]; Package: [650 Units]; Discontinued: 2017-01-24; Not in Commercial Distribution
GS1	00868665000069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113307

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-24

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