VivaGuard Ino Control Solution VGC01-373

GUDID 00840423500691

VivaGuard Ino Control Solution

ABOUND Diagnostics, Inc.

Glucose IVD, control

• Primary Device ID: 00840423500691
• NIH Device Record Key: 839edfaa-d250-4096-8b9a-3a9d2c3d8f61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VivaGuard Ino Control Solution
• Version Model Number: VGC01-373
• Catalog Number: VGC01-373
• Company DUNS: 119217208
• Company Name: ABOUND Diagnostics, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840423500035 [Primary]
GS1	00840423500691 [Package]; Contains: 00840423500035; Package: Carton [480 Units]; In Commercial Distribution

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: 2025-06-16
• Device Publish Date: 2025-06-06

Devices Manufactured by ABOUND Diagnostics, Inc.

• 00840423500684 - VivaGuard Ino Blood Glucose Test Strips: 2025-06-16 VivaGuard Ino Blood Glucose Test Strips
• 00840423500691 - VivaGuard Ino Control Solution: 2025-06-16VivaGuard Ino Control Solution
• 00840423500691 - VivaGuard Ino Control Solution: 2025-06-16 VivaGuard Ino Control Solution
• 00840423500707 - VivaGuard Ino Smart Blood Glucose Meter: 2025-06-16 VivaGuard Ino Smart Blood Glucose Meter
• 00840423500004 - VivaGuard Ino Blood Glucose Meter: 2025-06-11 VivaGuard Ino Blood Glucose Meter
• 00840423500516 - VivaGuard Lancets (21G): 2025-04-21 VivaGuard Lancets (21G)
• 00840423500509 - VivaGuard Lancets (23G): 2025-04-21 VivaGuard Lancets (23G)
• 00840423500400 - VivaGuard Lancets (26G): 2025-04-21 VivaGuard Lancets (26G)
• 00840423500103 - VivaGuard Lancets (28G): 2025-04-21 VivaGuard Lancets (28G)