Universal Gas Mixing Kit

Primary DI
00853480006150
Brand
Universal Gas Mixing Kit
Company
ESCALON MEDICAL CORP.
Model
9060-61
Catalog number
TR9060-61
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.
Published
2016-01-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BXXCalibrator, Pressure, Gas

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXXCalibrator, Pressure, GasAnesthesiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K923397000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K923397000SINGLE DOSE GAS INJECTOREscalon Medical Trek1992-09-14BXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10853480006157PackageGS110In Commercial Distribution
00853480006150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085348000615710853480006157
00853480006150008534800061508534800061500853480006150

GMDN Terms#

Term, Definition table
TermDefinition
Vitreoretinal gas injection setA 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.

Contacts#

Phone, Email table
PhoneEmail
800-486-4848info@escalonmed.com

Regulatory Flags#

DUNS number
879144426
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00853480006167Viscous Fluid Cannula9849-51TR9849-512016-01-14
00853480006020Fiber Optic Light GuideStandard, 20 ga, UniversalTR9800-112016-01-14
10853480006027Fiber Optic Light GuideStandard, 20 ga, UniversalTR9800-112016-01-14
00853480006037Fiber Optic Light GuideStandard, 20 ga, TREK/GreishaberTR9800-612016-01-14
00853480006044Fiber Optic Light Guide45°, 20 ga, UniversalTR9801-112016-01-14
00853480006051Fiber Optic Light Guide45°, 20 ga, TREK/GreishaberTR9801-612016-01-14
00853480006068Fiber Optic Light Guide45°Retinal Knife, UniversalTR9806-112016-01-14
00853480006075Fiber Optic Light Guide45° Retinal Knife, TREK/GreishaberTR9806-612016-01-14
00853480006082Fiber Optic Light GuideWide Angle, 20 ga, UniversalTR9821-112016-01-14
00853480006099Fiber Optic Light GuideWide Angle, 20 ga, TREK/GreishablerTR9821-612016-01-14
00853480006105Fiber Optic Light GuideSiepser ShieldedTR9879-112016-01-14
00853480006112Fiber Optic Light GuideDCR, 20 gaTR9880-112016-01-14
10853480006034Fiber Optic Light GuideStandard, 20 ga, TREK/GreishaberTR9800-612016-01-14
10853480006041Fiber Optic Light Guide45°, 20 ga, UniversalTR9801-112016-01-14
10853480006058Fiber Optic Light Guide45°, 20 ga, TREK/GreishaberTR9801-612016-01-14
10853480006065Fiber Optic Light Guide45°Retinal Knife, UniversalTR9806-112016-01-14
10853480006072Fiber Optic Light Guide45° Retinal Knife, TREK/GreishaberTR9806-612016-01-14
10853480006089Fiber Optic Light GuideWide Angle, 20 ga, UniversalTR9821-112016-01-14
10853480006096Fiber Optic Light GuideWide Angle, 20 ga, TREK/GreishablerTR9821-612016-01-14
10853480006102Fiber Optic Light GuideSiepser ShieldedTR9879-112016-01-14

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10853480006157Universal Gas Mixing KitESCALON MEDICAL CORP.BXX2016-01-15