FreeStyle Precision H 71181

GUDID 30093815711811

FreeStyle Precision H Blood Glucose and Ketone Monitoring System

ABBOTT DIABETES CARE INC

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

• Primary Device ID: 30093815711811
• NIH Device Record Key: 5f12193b-2089-442d-92cd-9993f1f3cab0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FreeStyle Precision H
• Version Model Number: 71181
• Catalog Number: 71181
• 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: false
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00093815711810 [Primary]
GS1	30093815711811 [Package]; Contains: 00093815711810; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070984

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 [FreeStyle Precision H]

• 30093815801161: FreeStyle Precision H Blood Glucose Test Strips
• 30093815711811: FreeStyle Precision H Blood Glucose and Ketone Monitoring System