Universal Gas Mixing Kit

Basic Information

• Brand Name: Universal Gas Mixing Kit
• Primary DI: 00853480006150
• Version / Model: 9060-61
• Catalog Number: TR9060-61
• Company Name: ESCALON MEDICAL CORP.
• Labeler DUNS: 879144426
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-01-15
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: f1800652-bfbd-4501-8ffc-2c712baf177b

Device Description

Convenient kit for the controlled and accurate mixing and dispensing of gases. Includes 3-way stopcock for drawing of gas or air, 0.2 micron filters provide for sterilization of gas and/or air, and 60cc syringe pre-marked with mixture percentages to eliminate guesswork during prepping. 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
BXX	Calibrator, Pressure, Gas	Anesthesiology	868.2620	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47242	Vitreoretinal gas injection set	A collection of devices used for the intraocular injection of certain ophthalmic gases [e.g., sulphur hexafluoride (SF6), hexafluoroethane (C2F6), octafluoropropane (C3F8), and their mixtures] for therapeutic purposes. It typically consists of dedicated syringes and micro-needles for the injection. The injected gases are used as an intraocular tamponade typically for fluid/gas exchange in vitreoretinal surgery, pneumatic retinopexy, management of complex retinal detachments, and macular hole surgery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10853480006157	GS1	Box	10	In Commercial Distribution
Primary	00853480006150	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K923397	000