Precision Xceed Pro 70935

GUDID 35021791709350

Precision Xceed Pro Blood ß-Ketone Test Strips

ABBOTT DIABETES CARE INC

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

• Primary Device ID: 35021791709350
• NIH Device Record Key: b5710df3-4aaa-48f2-9d00-666e99978049
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precision Xceed Pro
• Version Model Number: 70935
• Catalog Number: 70935
• 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(877)529-7185
• Email: xx@xx.xx

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00093815709350 [Primary]
GS1	10093815709357 [Unit of Use]
GS1	35021791709350 [Package]; Contains: 00093815709350; Package: Case [12 Units]; In Commercial Distribution
NDC/NHRIC	57599-0935-4 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080960

FDA Product Code

• NBW: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

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 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