FreeStyle Precision Neo 71741

GUDID 30357599000302

FreeStyle Precision Neo Blood Glucose Monitoring System Not For Retail Sale

ABBOTT DIABETES CARE INC

Glucose/ketone monitoring system IVD, home-use

• Primary Device ID: 30357599000302
• NIH Device Record Key: 4a6e2b94-8c15-44c4-b8ac-3ca003e5482d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FreeStyle Precision Neo
• Version Model Number: 71741
• Catalog Number: 71741
• 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: true
• Lot Batch: true
• Serial Number: true
• 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
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• 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
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• Phone: +1(800)527-3339
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• Phone: +1(800)527-3339
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• Phone: +1(800)527-3339
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• Phone: +1(800)527-3339
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• Phone: +1(800)527-3339
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• Phone: +1(800)527-3339
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• Phone: +1(800)527-3339
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• Phone: +1(800)527-3339
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• Phone: +1(800)527-3339
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• Phone: +1(800)527-3339
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• Phone: +1(800)527-3339
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• Phone: +1(800)527-3339
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• Phone: +1(800)527-3339
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• Phone: +1(800)527-3339
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• Phone: +1(800)527-3339
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• Phone: +1(800)527-3339
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• Phone: +1(800)527-3339
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• Phone: +1(800)527-3339
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• Phone: +1(800)527-3339
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• Phone: +1(800)527-3339
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• Phone: +1(800)527-3339
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• Phone: +1(800)527-3339
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• Phone: +1(800)527-3339
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• Phone: +1(800)527-3339
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• Phone: +1(800)527-3339
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• Phone: +1(800)527-3339
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Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00357599000301 [Primary]
GS1	30357599000302 [Package]; Contains: 00357599000301; Package: Case [4 Units]; In Commercial Distribution
NDC/NHRIC	57599-0000-30 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142928

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-06

On-Brand Devices [FreeStyle Precision Neo]

• 30357599000357: FreeStyle Precision Neo Blood Glucose Test Strips
• 30357599000340: FreeStyle Precision Neo Blood Glucose Test Strips
• 30357599000333: FreeStyle Precision Neo Blood Glucose Test Strips Not For Retail Sale
• 30357599000302: FreeStyle Precision Neo Blood Glucose Monitoring System Not For Retail Sale
• 30093815751756: FreeStyle Precision Neo Blood Glucose Monitoring System
• 30093815715819: FreeStyle Precision Neo Blood Glucose Test Strips
• 30093815715796: FreeStyle Precision Neo Blood Glucose Test Strips
• 30093815715772: FreeStyle Precision Neo Blood Glucose Test Strips