LIVE TULA Blood Glucose Control Solution W2

GUDID 00850065253213

TULA HEALTH, INC.

Glucose IVD, control

• Primary Device ID: 00850065253213
• NIH Device Record Key: 8d84d3b2-7a9e-484c-b85b-28277655e65d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIVE TULA Blood Glucose Control Solution W2
• Version Model Number: 4908A
• Company DUNS: 062385494
• Company Name: TULA HEALTH, 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850065253213 [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: 2024-12-16
• Device Publish Date: 2024-12-06

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