Carbon Dioxide Reagent 501-407

GUDID 00812137011947

For the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use only.

CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Carbon dioxide (CO2) IVD, reagent

• Primary Device ID: 00812137011947
• NIH Device Record Key: c44f711c-8180-4280-b685-7c3f0caae19c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carbon Dioxide Reagent
• Version Model Number: 120mL
• Catalog Number: 501-407
• Company DUNS: 048144997
• Company Name: CLINICAL DIAGNOSTIC SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: true
• 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: false

Customer Support Contacts

• Phone: 8004533328
• Email: quality@cdsolinc.com
• Phone: 8004533328
• Email: quality@cdsolinc.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812137011947 [Primary]

FDA Product Code

• KHS: Enzymatic, Carbon-Dioxide

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-06-11
• Device Publish Date: 2016-10-12

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