Viscous Fluid Pack

Basic Information

• Brand Name: Viscous Fluid Pack
• Primary DI: 00853480006013
• Version / Model: 8170-11
• Catalog Number: TR8170-11
• Company Name: ESCALON MEDICAL CORP.
• Labeler DUNS: 879144426
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-01-14
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 1bcc07e2-4975-49fc-944a-a20c46e0aa48

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MRH	Pump, Infusion, Ophthalmic	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35151	Eye-surface lavage system	A device assembly designed for automated or semi-automated irrigation and washing of the eye surface (i.e., sclera and cornea). It typically consists of a main electromechanical unit that may include a pump for infusion of non-medicated liquid (e.g., saline), an extractor, and controls for the temperature and the rate of irrigation; it may be coupled to special lenses (e.g., Morgan therapeutic) and/or to dedicated handpieces (e.g., Lewis), cannulae, catheters, and/or probes. The system is used to remove damaged tissue and/or debris (e.g., foreign objects) for ophthalmic procedures/surgery and in emergency departments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10853480006010	GS1	Box	10	In Commercial Distribution
Primary	00853480006013	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K963434	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius