FreeStyle Precision Pro 71411-70

GUDID 00093815714118

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: 00093815714118
• NIH Device Record Key: 70e37c0b-e2ad-4921-9604-c3e37b4b4dfa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FreeStyle Precision Pro
• Version Model Number: 71411-70
• Catalog Number: 71411-70
• 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
• 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
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00093815714118 [Primary]
GS1	00357599000592 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132511

FDA Product Code

• LFR: Glucose dehydrogenase, glucose

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-11
• Device Publish Date: 2016-08-12

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