Precision Xtra 99838

GUDID 30093815998380

Precision Xtra Blood Glucose Test Strips

ABBOTT DIABETES CARE INC

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

• Primary Device ID: 30093815998380
• NIH Device Record Key: 98e5305a-7ec2-42e0-8551-c48f62bed690
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precision Xtra
• Version Model Number: 99838
• Catalog Number: 99838
• Company DUNS: 966390890
• Company Name: ABBOTT DIABETES CARE INC
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00093815998389 [Primary]
GS1	10093815998386 [Unit of Use]
GS1	30093815998380 [Package]; Contains: 00093815998389; Package: Case [12 Units]; In Commercial Distribution
NDC/NHRIC	57599-9838-4 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051213

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: 2016-07-22

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