Viscous Fluid Pack TR8170-11

GUDID 10853480006010

Single-use procedure pack for injection and aspiration of silicone oil and other viscous fluids. Connects to Sonomed Escalon Viscous Fluid System, Trek VFI-10, Richard James FTS-50 and FTS-100 systems, Greishaber VIS, and others. Pack includes 10cc syringe with pressure-tested tubing and adapters, stainless steel cannula, and Teflon cannula. 0.2 micron filter included to maintain sterile field. Sterile, single-use.

ESCALON MEDICAL CORP.

Eye-surface lavage system

• Primary Device ID: 10853480006010
• NIH Device Record Key: 1bcc07e2-4975-49fc-944a-a20c46e0aa48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Viscous Fluid Pack
• Version Model Number: 8170-11
• Catalog Number: TR8170-11
• Company DUNS: 879144426
• Company Name: ESCALON MEDICAL CORP.
• 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

Customer Support Contacts

• Phone: 800-486-4848
• Email: info@escalonmed.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853480006013 [Primary]
GS1	10853480006010 [Package]; Contains: 00853480006013; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963434

FDA Product Code

• MRH: Pump, Infusion, Ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-01-14

On-Brand Devices [Viscous Fluid Pack]

• 10853480006249: Single-use procedure pack for injection and aspiration of silicone oil and other viscous fluids.
• 10853480006010: Single-use procedure pack for injection and aspiration of silicone oil and other viscous fluids.