FreeStyle Precision Pro 71284

GUDID 30093815712849

FreeStyle Precision Pro Blood Glucose Test Strips

ABBOTT DIABETES CARE INC

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

• Primary Device ID: 30093815712849
• NIH Device Record Key: 0d03798c-c0a4-4bc8-9364-75f5f7ff52a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FreeStyle Precision Pro
• Version Model Number: 71284
• Catalog Number: 71284
• Company DUNS: 966390890
• Company Name: ABBOTT DIABETES CARE INC
• Device Count: 100
• 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

• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A

Device Identifiers

Device Issuing Agency	Device ID
GS1	00093815712848 [Primary]
GS1	10093815712845 [Unit of Use]
GS1	30093815712849 [Package]; Contains: 00093815712848; Package: Case [6 Units]; In Commercial Distribution
NDC/NHRIC	57599-1284-5 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132511

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: 8
• Public Version Date: 2019-12-11
• Device Publish Date: 2016-07-22

On-Brand Devices [FreeStyle Precision Pro]

• 00093815714125: FreeStyle Precision Pro Blood Glucose and ß-Ketone Monitoring System
• 00093815714118: FreeStyle Precision Pro Blood Glucose and ß-Ketone Monitoring System
• 30093815712887: FreeStyle Precision Pro Blood ß-Ketone Test Strips
• 30093815712849: FreeStyle Precision Pro Blood Glucose Test Strips
• 00357599815004: FreeStyle Precision Pro Blood Glucose and ß-Ketone Monitoring System