Prodigy Control Solution Low 053310

GUDID 00384842533101

Prodigy Control Solution Low 4mL

PRODIGY DIABETES CARE, LLC

Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control

• Primary Device ID: 00384842533101
• NIH Device Record Key: 38882a82-3d38-49e7-b01c-94ab6fc8f12a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prodigy Control Solution Low
• Version Model Number: 053310
• Catalog Number: 053310
• 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: false
• 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 between 35.6°F to 86°F (2°C to 30°C). Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384840533103 [Primary]
GS1	00384842533101 [Package]; Contains: 00384840533103; Package: Corrugated Box [1000 Units]; In Commercial Distribution

FDA Product Code

• 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

On-Brand Devices [Prodigy Control Solution Low]

• 00384842903102: Prodigy Control Solution Low 4mL
• 00384842533101: Prodigy Control Solution Low 4mL