Rosie SmartMeter NFC Professional 3K-01-16003K

GUDID 00868665000045

Rosie SmartMeter NFC Professional Blood Glucose Meter

HMD BIOMEDICAL INC.

Glucose monitoring system IVD, point-of-care

• Primary Device ID: 00868665000045
• NIH Device Record Key: 4fe27720-b936-4971-aafe-0d41b1d01bed
• Commercial Distribution Discontinuation: 2016-12-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Rosie SmartMeter NFC Professional
• Version Model Number: AC-NFC Meter
• Catalog Number: 3K-01-16003K
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00389154000518 [Package]; Package: [63 Units]; Discontinued: 2016-12-07; Not in Commercial Distribution
GS1	00868665000045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140150

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

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: 2016-12-07

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