FreeStyle 14002

GUDID 20699073140023

FreeStyle Control Solution

ABBOTT DIABETES CARE INC

Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use

• Primary Device ID: 20699073140023
• NIH Device Record Key: c083d5e3-3651-4297-bc14-7a4449ac0761
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FreeStyle
• Version Model Number: 14002
• Catalog Number: 14002
• Company DUNS: 966390890
• Company Name: ABBOTT DIABETES CARE INC
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: true
• 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: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00699073140029 [Primary]
GS1	10699073140026 [Unit of Use]
GS1	20699073140023 [Package]; Contains: 00699073140029; Package: Case [6 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-16
• Device Publish Date: 2018-06-15

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