FreeStyle Precision Pro 72008-01

GUDID 00357599808006

FreeStyle Precision Pro Blood Glucose and ?-Ketone Monitoring System

ABBOTT DIABETES CARE INC

Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care Multiple clinical chemistry analyte monitoring system IVD, point-of-care

• Primary Device ID: 00357599808006
• NIH Device Record Key: 82ff1fed-7500-475b-8ec2-eb22e8146e15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FreeStyle Precision Pro
• Version Model Number: 72008-01
• Catalog Number: 72008-01
• Company DUNS: 966390890
• Company Name: ABBOTT DIABETES CARE 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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(877)529-7185
• Email: xx@xx.xx
• Phone: +1(877)529-7185
• Email: xx@xx.xx
• Phone: +1(877)529-7185
• Email: xx@xx.xx
• Phone: +1(877)529-7185
• Email: xx@xx.xx
• Phone: +1(877)529-7185
• Email: xx@xx.xx
• Phone: +1(877)529-7185
• Email: xx@xx.xx
• Phone: +1(877)529-7185
• Email: xx@xx.xx
• Phone: +1(877)529-7185
• Email: xx@xx.xx
• Phone: +1(877)529-7185
• Email: xx@xx.xx
• Phone: +1(877)529-7185
• Email: xx@xx.xx
• Phone: +1(877)529-7185
• Email: xx@xx.xx
• Phone: +1(877)529-7185
• Email: xx@xx.xx
• Phone: +1(877)529-7185
• Email: xx@xx.xx
• Phone: +1(877)529-7185
• Email: xx@xx.xx
• Phone: +1(877)529-7185
• Email: xx@xx.xx
• Phone: +1(877)529-7185
• Email: xx@xx.xx
• Phone: +1(877)529-7185
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00357599808006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132511

FDA Product Code

• NBW: System, test, blood glucose, over the counter

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: 2024-05-14
• Device Publish Date: 2020-04-15

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• 00357599808006: FreeStyle Precision Pro Blood Glucose and ?-Ketone Monitoring System
• 00357599807009: FreeStyle Precision Pro Blood Glucose and ?-Ketone Monitoring System