Precision Xceed Pro 70907-03

GUDID 00357599000189

Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System

ABBOTT DIABETES CARE INC

Glucose/ketone monitoring system IVD, home-use

• Primary Device ID: 00357599000189
• NIH Device Record Key: 76fc003a-8a87-49a3-b347-ba8649271226
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precision Xceed Pro
• Version Model Number: 70907-03
• Catalog Number: 70907-03
• 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
• 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
• 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
• 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
• 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
• 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
• 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	00357599000189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080960

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: 6
• Public Version Date: 2019-12-11
• Device Publish Date: 2016-08-12

On-Brand Devices [Precision Xceed Pro]

• 00357599000257: Precision Xceed Pro
• 00357599000189: Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System
• 00357599000158: Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System
• 00357599000134: Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System
• 35021791709350: Precision Xceed Pro Blood ß-Ketone Test Strips
• 30093815709320: Precision Xceed Pro Blood Glucose Test Strips