FDA.reportPublic FDA data

NA

Primary DI
10816765013110
Brand
NA
Company
US Endoscopy
Model
710304
Catalog number
710304
Device description
CO2 Endoscopic Insufflator Tubing Set
Published
2016-09-17
Public version status
Update
Distribution status
Not 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
K111648000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111648000BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATORBracco Diagnostic, Inc.2011-11-03FCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816765013110PackageGS124Not in Commercial Distribution
00816765013113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081676501311010816765013110
00816765013113008167650131138167650131130816765013113

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic insufflation tubing set, single-useA collection of sterile flexible tubing intended to be used as a conduit to deliver a medical gas [e.g., carbon dioxide (CO2), medical air] from its source for insufflation during an endoscopic (including laparoscopic, arthroscopic) procedure. It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
627879687
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
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
00724995182557Exacto00711094007110942021-03-31
00724995182564Exacto00711095007110952021-03-31
00724995182618Exacto00711115007111152021-03-31
00724995243746Exacto Mundo00711114007111142025-01-31
00724995180959VIA00717001007170012020-01-31
00724995181116VIA00717019007170192020-01-30
00724995181420VIA00717051007170512020-01-30
00724995181451VIA00717054007170542020-01-30
00724995181505VIA00717059007170592020-01-30
00724995181659VIA00717076007170762020-01-30
00724995182984VIA00717141007171412020-01-30
00724995183073VIA00717155007171552020-07-16
00724995183141VIA00717167007171672020-01-30
00724995183257VIA00717182007171822020-01-30
00724995190699VIA00717223007172232020-01-30
00724995190736VIA00717234007172342020-01-30
00724995193966VIA00717269007172692020-02-04
00724995194123VIA00717229007172292020-02-07
00724995194987VIA00717310007173102020-03-23
00724995203412VIA00717337007173372020-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842942017315PRIMEDpriMED Medical Products IncFCX2025-07-14
10842942017312PRIMEDpriMED Medical Products IncFCX2025-07-14
30815112021703Two Tank Shuttle Valve SystemBracco Diagnostics Inc.FCX2025-06-30
30815112021710DIN 477 High Pressure Hose for CO2Bracco Diagnostics Inc.FCX2025-06-30
10815112021570Protocol Administration Set With Flexi-Cuff Retention Tip Bracco Diagnostics Inc.FCX2025-05-16
30815112021574Protocol Administration Set With Flexi-Cuff Retention Tip Bracco Diagnostics Inc.FCX2025-05-16
04953170467219HIGH FLOW INSUFFLATION UNITOLYMPUS MEDICAL SYSTEMS CORP.FCX2025-02-27
00724995228897CO2MPACTUS EndoscopyFCX2024-11-25
04953170465963ENDOSCOPIC CO2 REGULATION UNITOLYMPUS MEDICAL SYSTEMS CORP.FCX2024-11-25
04055207007754NARichard Wolf GmbHFCX2024-08-19
04055207007761NARichard Wolf GmbHFCX2024-08-19
04055207007778NARichard Wolf GmbHFCX2024-08-19
04055207069875NARichard Wolf GmbHFCX2024-08-19
04055207069882NARichard Wolf GmbHFCX2024-08-19
04055207069899NARichard Wolf GmbHFCX2024-08-19
05391536920364Erbe ECO2 plusPALLIARE LIMITEDFCX2024-07-31
05391536920296EVA 5 InsufflatorPALLIARE LIMITEDFCX2024-05-16
06936534332246CO2 Source TubingZhejiang Chuangxiang Medical Technology Co., LTD.FCX2023-10-24
10815112021235Protocol Touch Colon InsufflatorBracco Diagnostics Inc.FCX2023-08-31
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
30815112021260Protocol Accessory CartBRACCO DIAGNOSTICS INCFCX2023-07-07
10815112021242Protocol Touch Administration Set with Small Catheter and Retention CuffBracco Diagnostics Inc.FCX2023-06-29
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
30815112021284Protocol Administration Set with Small Catheter and Retention CuffBRACCO DIAGNOSTICS INCFCX2023-06-29
04547410366037FUJIFILMFUJIFILM CORPORATIONFCX2022-10-07
04897106953790andorate® CO2 Extend Tubing with Luer ConnectorGA Health Company LimitedFCX2022-02-23