Rosie SmartMeter Professional Strip 3L-10-16003E

GUDID 00389454000525

Rosie SmartMeter Professional Strip-Foil

HMD BIOMEDICAL INC.

Glucose monitoring system IVD, point-of-care

• Primary Device ID: 00389454000525
• NIH Device Record Key: 5c0df941-c310-44ec-a2fa-89921d9fe9a7
• Commercial Distribution Discontinuation: 2016-12-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Rosie SmartMeter Professional Strip
• Version Model Number: AC-11 Pro-Strip
• Catalog Number: 3L-10-16003E
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00389454000525 [Package]; Contains: 00868665000052; Package: [240 Units]; Discontinued: 2016-12-07; Not in Commercial Distribution
GS1	00868665000052 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-07

On-Brand Devices [Rosie SmartMeter Professional Strip]

• 00389454000525: Rosie SmartMeter Professional Strip-Foil
• 03894540005253: Rosie SmartMeter Professional Strip-Foil