AccessGUDID - DEVICE: Universal Gas Mixing Kit (00853480006150)

GUDID

Device Identifier (DI) Information

Brand Name: Universal Gas Mixing Kit
Version or Model: 9060-61
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TR9060-61
Company Name: ESCALON MEDICAL CORP.

Primary DI Number: 00853480006150
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 879144426 *Terms of Use

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

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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BXX	Calibrator, Pressure, Gas

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K923397	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f1800652-bfbd-4501-8ffc-2c712baf177b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 15, 2016