ChloroChek® Standard Solution, 100 mmol/L, 10x1mL

GUDID 03661540304101

ELITechGroup Inc CHLOROCHEK Standard Solution is an aqueous solution used to conditioning or check the performance of ChloroChek Chloridometer by qualified personnel.

ELITECHGROUP INC.

Chloride (Cl-) IVD, calibrator

• Primary Device ID: 03661540304101
• NIH Device Record Key: 151ad4ae-fdde-4119-af50-0ab999c63d6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ChloroChek® Standard Solution, 100 mmol/L, 10x1mL
• Version Model Number: SS-251
• Company DUNS: 052423787
• Company Name: ELITECHGROUP INC.
• 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: true
• 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: false

Customer Support Contacts

• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgroup.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661540304101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121823

FDA Product Code

• JIS: Calibrator, Primary

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: 2021-03-01
• Device Publish Date: 2021-02-19

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