FreeStyle Precision Pro 72011-01

GUDID 00357599815004

FreeStyle Precision Pro Blood Glucose and ß-Ketone Monitoring System

ABBOTT DIABETES CARE INC

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

• Primary Device ID: 00357599815004
• NIH Device Record Key: f2cca906-4bd8-48cf-a15d-ef60d114ddd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FreeStyle Precision Pro
• Version Model Number: 72011-01
• Catalog Number: 72011-01
• 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: true

Customer Support Contacts

• Phone: +1(877)529-7185
• Email: xx@xx.xx

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00357599807009 [Primary]
GS1	00357599808006 [Primary]
GS1	00357599815004 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132511

FDA Product Code

• JQP: Calculator/data processing module, for clinical use
• NBW: System, test, blood glucose, over the counter

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: 2020-04-23
• Device Publish Date: 2020-04-15

On-Brand Devices [FreeStyle Precision Pro]

• 00093815714125: FreeStyle Precision Pro Blood Glucose and ß-Ketone Monitoring System
• 00093815714118: FreeStyle Precision Pro Blood Glucose and ß-Ketone Monitoring System
• 30093815712887: FreeStyle Precision Pro Blood ß-Ketone Test Strips
• 30093815712849: FreeStyle Precision Pro Blood Glucose Test Strips
• 00357599815004: FreeStyle Precision Pro Blood Glucose and ß-Ketone Monitoring System