Prodigy No Coding Blood Glucose Test Strips 075300

GUDID 00384840753006

1 Box of Prodigy No Coding Blood Glucose Test Strips (50 ct).

PRODIGY DIABETES CARE, LLC

Glucose IVD, kit, electrometry

• Primary Device ID: 00384840753006
• NIH Device Record Key: fda7a56d-0a63-4f28-ab68-bd87093a619c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prodigy No Coding Blood Glucose Test Strips
• Version Model Number: 075300
• Catalog Number: 075300
• Company DUNS: 832875905
• Company Name: PRODIGY DIABETES CARE, LLC
• Device Count: 50
• 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: false
• 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384840753006 [Primary]
GS1	00384841753005 [Unit of Use]
GS1	00384843753003 [Package]; Package: Corrugated Carton [20 Units]; In Commercial Distribution
GS1	00384844753002 [Package]; Contains: 00384843753003; Package: Corrugated Carton [10 Units]; In Commercial Distribution

FDA Product Code

• CGA: Glucose Oxidase, 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-21

On-Brand Devices [Prodigy No Coding Blood Glucose Test Strips]

• 00384840753006: 1 Box of Prodigy No Coding Blood Glucose Test Strips (50 ct).
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• 00384844725009: 1 Box of Prodigy No Coding Blood Glucose Test Strips (50 ct).
• 00384844528259: 1 Box of Prodigy No Coding Blood Glucose Test Strips (25 ct).
• 00384840528109: 1 Vial of Prodigy No Coding Blood Glucose Test Strips (10 ct).
• 00384840528000: 1 Box of Prodigy No Coding Blood Glucose Test Strips (50 ct).
• 00384843104003: 1 Box of Prodigy No Coding Blood Glucose Test Strips for eCommerce (50 ct)