Prodigy Control Solution High 053350

GUDID 00384842533507

Prodigy Control Solution High 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: 00384842533507
• NIH Device Record Key: 96bfc6b7-4dfd-478f-a193-8f6b97b33892
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prodigy Control Solution High
• Version Model Number: 053350
• Catalog Number: 053350
• 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	00384840533509 [Primary]
GS1	00384842533507 [Package]; Contains: 00384840533509; Package: Corrugated Carton [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

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