Instinct 78893

GUDID 30357599880003

Instinct Sensor

ABBOTT DIABETES CARE INC

Percutaneous interstitial fluid glucose monitoring system, electrochemical

• Primary Device ID: 30357599880003
• NIH Device Record Key: 8c86b2bb-9d5d-483f-ac18-5fecaba3e39a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Instinct
• Version Model Number: 78893
• Catalog Number: 78893
• Company DUNS: 966390890
• Company Name: ABBOTT DIABETES CARE INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)-646-4633
• Email: customerexperience@medtronic.com
• Phone: +1(800)-646-4633
• Email: customerexperience@medtronic.com
• Phone: +1(800)-646-4633
• Email: customerexperience@medtronic.com
• Phone: +1(800)-646-4633
• Email: customerexperience@medtronic.com
• Phone: +1(800)-646-4633
• Email: customerexperience@medtronic.com
• Phone: +1(800)-646-4633
• Email: customerexperience@medtronic.com
• Phone: +1(800)-646-4633
• Email: customerexperience@medtronic.com
• Phone: +1(800)-646-4633
• Email: customerexperience@medtronic.com
• Phone: +1(800)-646-4633
• Email: customerexperience@medtronic.com
• Phone: +1(800)-646-4633
• Email: customerexperience@medtronic.com
• Phone: +1(800)-646-4633
• Email: customerexperience@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00357599880002 [Primary]
GS1	30357599880003 [Package]; Contains: 00357599880002; Package: Case [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233537

FDA Product Code

• QBJ: Integrated Continuous Glucose Monitoring system, factory calibrated

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[30357599880003]

Radiation Sterilization

[30357599880003]

Radiation Sterilization

[30357599880003]

Radiation Sterilization

[30357599880003]

Radiation Sterilization

[30357599880003]

Radiation Sterilization

[30357599880003]

Radiation Sterilization

[30357599880003]

Radiation Sterilization

[30357599880003]

Radiation Sterilization

[30357599880003]

Radiation Sterilization

[30357599880003]

Radiation Sterilization

[30357599880003]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-30
• Device Publish Date: 2025-09-22

Devices Manufactured by ABBOTT DIABETES CARE INC

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• 30357599880003 - Instinct: 2025-09-30 Instinct Sensor
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• 00357599804015 - FreeStyle Libre 2: 2025-08-04 FreeStyle Libre 2 Flash Glucose Monitoring System Reader
• 30357599805013 - FreeStyle Libre 2: 2025-08-04 FreeStyle Libre 2 Flash Glucose Monitoring System Reader
• 30357599820016 - FreeStyle Libre 3: 2025-08-04 FreeStyle Libre 3 Continuous Glucose Monitoring System Reader
• 30357599835010 - FreeStyle Libre 2 Plus: 2025-08-04 FreeStyle Libre 2 Plus Sensor
• 30357599836017 - FreeStyle Libre 2 Plus: 2025-08-04 FreeStyle Libre 2 Plus Sensor Not For Retail Sale
• 30357599842018 - FreeStyle Libre 3: 2025-08-04 FreeStyle Libre 3 Continuous Glucose Monitoring System Reader