Diska NuLife

GUDID 00810115892465

Control Solution

Diska LLC

Glucose monitoring system IVD, home-use

• Primary Device ID: 00810115892465
• NIH Device Record Key: 6f64f480-2d9c-41b9-804c-7623cffad28f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diska NuLife
• Version Model Number: DNL-VGC01
• Company DUNS: 006311259
• Company Name: Diska LLC
• 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810115892458 [Primary]
GS1	00810115892465 [Package]; Contains: 00810115892458; Package: Case [400 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: 2023-10-13
• Device Publish Date: 2023-10-05

On-Brand Devices [Diska NuLife]

• 00810115891246: Blue Nitrile Gloves - Single box(Large)
• 00810115891390: Clear Vinyl Gloves - Single box(X-large)
• 00810115891338: Clear Vinyl Gloves - Single box (Medium)
• 00810115891307: Clear Vinyl Gloves - Single box(small)
• 00810115891277: Blue Nitrile Gloves - Single box(X-large)
• 00810115891215: Blue Nitrile Gloves - Single box (Medium)
• 00810115891185: Blue Nitrile Gloves - Single box(small)
• 00810115891154: Black Nitrile gloves - Single box(X-large)
• 00810115891123: Black Nitrile gloves - Single box(Large)
• 00810115891093: Black Nitrile gloves - Single box (Medium)
• 00810115891062: Black Nitrile gloves - Single box(small)
• 00810115891406: Weight scale
• 00810115890782: BP Monitor
• 00810115891369: Clear Vinyl Gloves - Single box(Large)
• 00810115891734: Single Use Lancets
• 00810115891703: Blood Glucose Test Strips
• 00810115891673: Control Solution
• 00810115891659: Lancing Device
• 00810115891598: Blood Glucose Meter
• 00810115892465: Control Solution
• 00810115892441: Strips
• 00810115892403: BLE Pulse Oximeter
• 00810115892373: BLE Weight Scale with Glass Platform
• 00810115892359: BLE Glucometer
• 00810115892335: BLE Blood Pressure Monitor