UniStrip Control Solution Low 036210

GUDID 00389167262101

UniStrip Control Solution Low 4mL

UNISTRIP TECHNOLOGIES, LLC

Glucose IVD, control

• Primary Device ID: 00389167262101
• NIH Device Record Key: 5c59d994-53d9-4f30-bc80-de28235e79bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UniStrip Control Solution Low
• Version Model Number: 036210
• Catalog Number: 036210
• Company DUNS: 043251054
• Company Name: UNISTRIP TECHNOLOGIES, 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	00389167262101 [Package]; Contains: 00389167362108; Package: Corrugated Carton [1000 Units]; In Commercial Distribution
GS1	00389167362108 [Primary]

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: 2016-09-23

Devices Manufactured by UNISTRIP TECHNOLOGIES, LLC

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• 00389167348508 - UniStrip1 Generic Blood Glucose Test Strip: 2018-03-29 UniStrip1 Generic Blood Glucose Test Strips (50 ct) For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart Meters purchase
• 00389167262101 - UniStrip Control Solution Low: 2018-03-29UniStrip Control Solution Low 4mL
• 00389167262101 - UniStrip Control Solution Low: 2018-03-29 UniStrip Control Solution Low 4mL