Rosie SmartMeter delete

GUDID 00389154000501

Rosie SmartMeter NFC Professional Blood Glucose Monitoring System (Rosie SmartMeter NFC Professional)

HMD BIOMEDICAL INC.

Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care

• Primary Device ID: 00389154000501
• NIH Device Record Key: 520b3c99-924a-47c5-89fa-ff3e88ab1a81
• Commercial Distribution Discontinuation: 2017-03-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Rosie SmartMeter
• Version Model Number: AC11-NFC
• Catalog Number: delete
• 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	00389154000501 [Primary]
GS1	389154000518 [Package]; Package: [63 Units]; Discontinued: 2017-03-13; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140150

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: 2016-09-09

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