LIVE TULA Lancing Device

GUDID 00850065253305

TULA HEALTH, INC.

Manual blood lancing device, reusable

• Primary Device ID: 00850065253305
• NIH Device Record Key: a5febb3d-0365-41f8-aec6-64d98b585e79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIVE TULA Lancing Device
• Version Model Number: TD-5011
• 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: false
• 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	00850065253305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221419

FDA Product Code

• QRL: Multiple Use Blood Lancet For Single Patient Use Only

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: 2025-12-11
• Device Publish Date: 2025-12-03

Devices Manufactured by TULA HEALTH, INC.

• 00850065253305 - LIVE TULA Lancing Device: 2025-12-11
• 00850065253305 - LIVE TULA Lancing Device: 2025-12-11
• 00850065253275 - LIVE TULA LT-THIN Lancets(100PCS/BOX): 2025-04-28
• 00850065253244 - LIVE TULA Alcohol Pads 1.0 (100pcs/box): 2025-03-26
• 00850065253213 - LIVE TULA Blood Glucose Control Solution W2: 2024-12-16
• 00860012134007 - Blood Glucose Monitoring System LIVE TULA: 2024-06-24
• 00860012134021 - Blood Glucose Test Strips (50pcs/box) LIVE TULA: 2024-06-24