POGO Automatic Blood Glucose Monitoring System 00856176008001

GUDID 00856176008001

Blood Glucose Meter

INTUITY MEDICAL, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 00856176008001
• NIH Device Record Key: 08672f96-51a9-45e7-b58c-9383f9e3f535
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POGO Automatic Blood Glucose Monitoring System
• Version Model Number: 00856176008001
• Catalog Number: 00856176008001
• Company DUNS: 941150349
• Company Name: INTUITY MEDICAL, 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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: 1-855-464-7646
• Email: support@presspogohelp.com
• Phone: 1-855-464-7646
• Email: support@presspogohelp.com
• Phone: 1-855-464-7646
• Email: support@presspogohelp.com
• Phone: 1-855-464-7646
• Email: support@presspogohelp.com
• Phone: 1-855-464-7646
• Email: support@presspogohelp.com
• Phone: 1-855-464-7646
• Email: support@presspogohelp.com
• Phone: 1-855-464-7646
• Email: support@presspogohelp.com
• Phone: 1-855-464-7646
• Email: support@presspogohelp.com
• Phone: 1-855-464-7646
• Email: support@presspogohelp.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856176008001 [Primary]
GS1	50856176008006 [Package]; Package: Case [6 Units]; In Commercial Distribution

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-10
• Device Publish Date: 2020-02-02

Devices Manufactured by INTUITY MEDICAL, INC.

• 00856176008001 - POGO Automatic Blood Glucose Monitoring System: 2020-02-10Blood Glucose Meter
• 00856176008001 - POGO Automatic Blood Glucose Monitoring System: 2020-02-10 Blood Glucose Meter
• 00856176008025 - POGO Automatic Control Solution: 2020-02-10 Level 1 Control Solution (75 mg/dL)
• 00856176008032 - POGO Automatic Control Solution: 2020-02-10 Level 2 Control Solution (150 mg/dL)
• 00856176008056 - POGO Automatic Test Cartridges: 2020-02-10 Blood glucose test cartridges with 10 tests per cartridge. Five cartridges per tube (50 tests)