FDA.reportPublic FDA data

Gasjet CO2 Delivery System

Primary DI
30677964085575
Brand
Gasjet CO2 Delivery System
Company
MEDIVATORS INC.
Model
EGA-501T
Published
2017-05-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FCXInsufflator, Automatic Carbon-Dioxide For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCXInsufflator, Automatic Carbon-Dioxide For EndoscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113310000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113310000ENDOGATER AVANTAGE CO2 INSUFFLATORByrne Medical, Inc.2012-06-20FCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30677964085575PackageGS11In Commercial Distribution
00677964085574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3067796408557530677964085575
00677964085574006779640855746779640855740677964085574

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal endoscopic insufflatorA mains electricity (AC-powered) device intended to be used during an endoscopic procedure to distend (expand by pressure) the lumen of the colon or other portion of the gastrointestinal (GI) tract, and/or improve endoscopic visualization (e.g., prevent dew/mist accumulating at the lens) through the pressure-limited introduction of medical gas [e.g., carbon dioxide (CO2)]. Electronics assist in monitoring the pressure and maintaining the gas-filled space by compensating for gas leakage. This device may also be referred to as a gas distention system.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)444-4729custserv@MEDIVATORS.com

Regulatory Flags#

DUNS number
068199363
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00677964153617Endo Carry-on Procedure Kit401122140112212026-05-26
00677964153624Endo Carry-on Procedure Kit401124240112422026-05-26
00677964153631Endo Carry-on Procedure Kit401123040112302026-05-26
00677964153648Endo Carry-on Procedure Kit401124340112432026-05-26
00677964153655Endo Carry-on Procedure Kit401124440112442026-05-26
00677964153662Endo Carry-on Procedure Kit401124540112452026-05-26
00677964153679Endo Carry-on Procedure Kit401121440112142026-05-26
00677964153686Endo Carry-on Procedure Kit401123640112362026-05-26
00677964153693Endo Carry-on Procedure Kit401123740112372026-05-26
00677964153709Endo Carry-on Procedure Kit401123840112382026-05-26
00677964153716Endo Carry-on Procedure Kit401125040112502026-05-26
00677964153723Endo Carry-on Procedure Kit401125240112522026-05-26
00677964153730Endo Carry-on Procedure Kit401123940112392026-05-26
00677964153747Endo Carry-on Procedure Kit401125140112512026-05-26
00677964153754Endo Carry-on Procedure Kit401125340112532026-05-26
00677964153761Endo Carry-on Procedure Kit401125440112542026-05-26
00677964153778Endo Carry-on Procedure Kit401136040113602026-05-26
00677964153785Endo Carry-on Procedure Kit401136140113612026-05-26
00677964057281Endo Carry-On Procedure Kit1008491008492018-06-22
00677964153488Endo Carry-on Procedure Kit401119340111932026-04-29

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Primary DI, Brand, Company table
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04953170467219HIGH FLOW INSUFFLATION UNITOLYMPUS MEDICAL SYSTEMS CORP.FCX2025-02-27
00724995228897CO2MPACTUS EndoscopyFCX2024-11-25
04953170465963ENDOSCOPIC CO2 REGULATION UNITOLYMPUS MEDICAL SYSTEMS CORP.FCX2024-11-25
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30815112021239Protocol Touch Colon InsufflatorBRACCO DIAGNOSTICS INCFCX2023-08-31
30815112021253DIN 477 High Pressure Hose for CO2Bracco Diagnostics Inc.FCX2023-08-31
30815112021291High Pressure Hose and YokeBracco Diagnostics Inc.FCX2023-08-31
10815112021266Protocol Accessory CartBracco Diagnostics Inc.FCX2023-07-07
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10815112021280Protocol Administration Set with Small Catheter and Retention CuffBracco Diagnostics Inc.FCX2023-06-29
30815112021246Protocol Touch Administration Set with Small Catheter and Retention CuffBRACCO DIAGNOSTICS INCFCX2023-06-29
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04547410366037FUJIFILMFUJIFILM CORPORATIONFCX2022-10-07
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