Universal Gas Mixing Kit

Primary DI
10853480006157
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
OTC
false
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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
879144426
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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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