AccessGUDID - DEVICE: Viscous Fluid Pack (00853480006013)

GUDID

Device Identifier (DI) Information

Brand Name: Viscous Fluid Pack
Version or Model: 8170-11
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TR8170-11
Company Name: ESCALON MEDICAL CORP.

Primary DI Number: 00853480006013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 879144426 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MRH	Pump, Infusion, Ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K963434	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1bcc07e2-4975-49fc-944a-a20c46e0aa48
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 14, 2016