Prodigy No Coding Blood Glucose Test Strips 010400

GUDID 00384843104003

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

Prodigy Diabetes Care, LLC

Glucose IVD, kit, electrometry

• Primary Device ID: 00384843104003
• NIH Device Record Key: 3a4171a7-e5cc-44d5-bc7d-801a946ff3d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prodigy No Coding Blood Glucose Test Strips
• Version Model Number: 010400
• Catalog Number: 010400
• 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: 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384840104006 [Primary]
GS1	00384843104003 [Package]; Contains: 00384840104006; Package: Inner Case [20 Units]; In Commercial Distribution
GS1	00384844104002 [Package]; Contains: 00384840104006; Package: Master Case [200 Units]; In Commercial Distribution
NDC/NHRIC	3 84840 10400 [Secondary]

FDA Product Code

• CGA: Glucose Oxidase, Glucose

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-18
• Device Publish Date: 2024-07-10

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