Prodigy AutoCode Blood Glucose Monitoring System 051890

GUDID 00038481518505

Prodigy AutoCode Blood Glucose Monitoring System (KIT)

PRODIGY DIABETES CARE, LLC

Manual blood lancing device, reusable

• Primary Device ID: 00038481518505
• NIH Device Record Key: f162915c-1c98-462f-8a1f-c870e1b3c976
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prodigy AutoCode Blood Glucose Monitoring System
• Version Model Number: 051890
• Catalog Number: 051890
• 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 between 39.2°F to 86°F (4°C to 30°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 39.2°F to 86°F (4°C to 30°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 39.2°F to 86°F (4°C to 30°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 39.2°F to 86°F (4°C to 30°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 39.2°F to 86°F (4°C to 30°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 39.2°F to 86°F (4°C to 30°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 39.2°F to 86°F (4°C to 30°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 39.2°F to 86°F (4°C to 30°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 39.2°F to 86°F (4°C to 30°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 39.2°F to 86°F (4°C to 30°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 39.2°F to 86°F (4°C to 30°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 39.2°F to 86°F (4°C to 30°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 39.2°F to 86°F (4°C to 30°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 39.2°F to 86°F (4°C to 30°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 39.2°F to 86°F (4°C to 30°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 39.2°F to 86°F (4°C to 30°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 39.2°F to 86°F (4°C to 30°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 39.2°F to 86°F (4°C to 30°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 39.2°F to 86°F (4°C to 30°C) and 10% - 85% R.H.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00038481518505 [Direct Marking]
GS1	00384840518902 [Primary]
GS1	00384843518909 [Package]; Contains: 00384840518902; Package: Corrugated Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073118

FDA Product Code

• JJT: Enzyme 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [Prodigy AutoCode Blood Glucose Monitoring System]

• 00384841518505: Prodigy AutoCode Blood Glucose Monitoring System (Meter Only)
• 00038481518505: Prodigy AutoCode Blood Glucose Monitoring System (KIT)