Prodigy Voice Blood Glucose Monitoring System 051900

GUDID 00384841519007

Prodigy Voice Blood Glucose Monitoring System (KIT)

PRODIGY DIABETES CARE, LLC

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• Primary Device ID: 00384841519007
• NIH Device Record Key: 981d2a06-458f-4f78-b64b-9042087a9513
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prodigy Voice Blood Glucose Monitoring System
• Version Model Number: 051900
• Catalog Number: 051900
• Company DUNS: 832875905
• Company Name: PRODIGY DIABETES CARE, LLC
• 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: true
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384840519008 [Primary]
GS1	00384840719507 [Primary]
GS1	00384841519007 [Direct Marking]
GS1	00384843519005 [Package]; Contains: 00384840519008; Package: Corrugated Carton [10 Units]; In Commercial Distribution
GS1	00384843719504 [Package]; Contains: 00384840719507; Package: Corrugated Carton [10 Units]; In Commercial Distribution

FDA Product Code

• FMK: Lancet, Blood
• 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-22

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