Rosie SmartMeter Test Strips 50ct(vial) 3S-01-16003A

GUDID 00868665000076

Rosie SmartMeter Blood Glucose GDH-FAD Test Strips

HMD BIOMEDICAL INC.

Glucose monitoring system IVD, point-of-care

• Primary Device ID: 00868665000076
• NIH Device Record Key: 03078833-f1dc-431f-a9c8-800e90adab47
• Commercial Distribution Discontinuation: 2017-01-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Rosie SmartMeter Test Strips 50ct(vial)
• Version Model Number: 3S-01-16003A
• Catalog Number: 3S-01-16003A
• 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 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00389154000488 [Package]; Package: [400 Units]; Discontinued: 2017-01-24; Not in Commercial Distribution
GS1	00868665000076 [Primary]

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: 2017-01-24

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