Precision Xtra 98814

GUDID 30093815988145

Precision Xtra Blood Glucose & Ketone Monitoring System

ABBOTT DIABETES CARE INC

Glucose/ketone monitoring system IVD, home-use

• Primary Device ID: 30093815988145
• NIH Device Record Key: d3032351-c151-42f7-8b3f-90b919ab688b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precision Xtra
• Version Model Number: 98814
• Catalog Number: 98814
• 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: true
• 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(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00093815988144 [Primary]
GS1	30093815988145 [Package]; Contains: 00093815988144; Package: Case [4 Units]; In Commercial Distribution
NDC/NHRIC	57599-8814-1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040814

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 [Precision Xtra]

• 30093815998786: Precision Xtra Blood Glucose Test Strips
• 30093815998779: Precision Xtra Blood Glucose Test Strips
• 30093815998380: Precision Xtra Blood Glucose Test Strips
• 30093815998373: Precision Xtra Blood Glucose & Ketone Monitoring System
• 40093815997281: Precision Xtra Blood Glucose Test Strips
• 30093815996959: Precision Xtra Blood Glucose Test Strips
• 30093815996942: Precision Xtra Blood Glucose Test Strips
• 30093815988145: Precision Xtra Blood Glucose & Ketone Monitoring System
• 30093815800508: Precision Xtra Blood Glucose Test Strips
• 30093815715024: Precision Xtra Blood Glucose & Ketone Monitoring System
• 30093815707463: Precision Xtra Blood ß-Ketone Test Strips
• 30093815707456: Precision Xtra Blood ß-Ketone Test Strips