FreeStyle Precision Pro 71288

GUDID 30093815712887

FreeStyle Precision Pro Blood ß-Ketone Test Strips

ABBOTT DIABETES CARE INC

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

• Primary Device ID: 30093815712887
• NIH Device Record Key: 4478ff9c-b178-45bb-ab61-81f3ada15082
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FreeStyle Precision Pro
• Version Model Number: 71288
• Catalog Number: 71288
• 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	00093815712886 [Primary]
GS1	10093815712883 [Unit of Use]
GS1	30093815712887 [Package]; Contains: 00093815712886; Package: Case [12 Units]; In Commercial Distribution
NDC/NHRIC	57599-1288-4 [Secondary]

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: 7
• Public Version Date: 2019-12-11
• Device Publish Date: 2016-08-12

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