ViviGen MIS Delivery System BL-1900-GUN

GUDID 00889858625203

Delivery System Dispenser

LIFENET HEALTH

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• Primary Device ID: 00889858625203
• NIH Device Record Key: a1278229-7484-45f4-9096-4f04b4a1ccb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViviGen MIS Delivery System
• Version Model Number: BL-1900-GUN
• Catalog Number: BL-1900-GUN
• Company DUNS: 121828156
• Company Name: LIFENET HEALTH
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889858625203 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201338

FDA Product Code

• FMF: Syringe, Piston

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-27
• Device Publish Date: 2021-05-19

On-Brand Devices [ViviGen MIS Delivery System]

• 00889858628402: Delivery System Cannula
• 00889858625203: Delivery System Dispenser
• 00889858628419: Delivery System Cannula
• 00889858640244: Delivery System Cannula