Universal Gas Mixing Kit TR9060-61

GUDID 10853480006157

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.

ESCALON MEDICAL CORP.

Vitreoretinal gas injection set

• Primary Device ID: 10853480006157
• NIH Device Record Key: f1800652-bfbd-4501-8ffc-2c712baf177b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal Gas Mixing Kit
• Version Model Number: 9060-61
• Catalog Number: TR9060-61
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853480006150 [Primary]
GS1	10853480006157 [Package]; Contains: 00853480006150; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923397

FDA Product Code

• BXX: Calibrator, Pressure, Gas

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: 2016-01-15

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