POGO Automatic Control Solution 00856176008025

GUDID 00856176008025

Level 1 Control Solution (75 mg/dL)

INTUITY MEDICAL, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 00856176008025
• NIH Device Record Key: e19602bc-6b21-4484-89da-dffbce81b058
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POGO Automatic Control Solution
• Version Model Number: 00856176008025
• Catalog Number: 00856176008025
• Company DUNS: 941150349
• Company Name: INTUITY MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 1-855-464-7646
• Email: support@presspogohelp.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856176008025 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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

On-Brand Devices [POGO Automatic Control Solution]

• 00856176008032: Level 2 Control Solution (150 mg/dL)
• 00856176008025: Level 1 Control Solution (75 mg/dL)