FDA.reportPublic FDA data

Protocol Touch Colon Insufflator

Primary DI
10815112021235
Brand
Protocol Touch Colon Insufflator
Company
Bracco Diagnostics Inc.
Model
390308
Catalog number
390308
Device description
Protocol Touch Colon Insufflator
Published
2023-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30815112021239PackageGS11In Commercial Distribution
10815112021235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081511202123930815112021239
1081511202123510815112021235

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.

Contacts#

Phone, Email table
PhoneEmail
609-514-2200xx@xx.xx

Regulatory Flags#

DUNS number
849234661
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10815112020214Fast Find Grid: Disposable CT Biopsy Grid6000016000012016-09-19
10815112021167Rounded Flexi Tip Adult Enema Tip9013019013012023-05-25
10815112021181Miller Enema Air Tip with Non-Latex Retention Cuff9012019012012023-05-25
10815112021198Miller Enema Air Tip with Retention Cuff9012029012022023-05-25
30815112021703Two Tank Shuttle Valve System7106027106022025-06-30
30815112021710DIN 477 High Pressure Hose for CO23905133905132025-06-30
30815112021291High Pressure Hose and Yoke7106037106032023-08-31
10815112021174Enema Kit: Empty Enema Bag Delivery System9003029003022023-05-25
1081511202120418 French Pediatric Flexi Tip9013089013082023-05-25
30815112020805High Pressure DISS Hose For CO27106047106042016-09-19
30815112020782Two Tank Shuttle Valve System7106027106022016-09-19
10815112020535E-Z-GEL UltraSound Gel6010016010012016-09-23
10815112020542E-Z-SCAN Low Viscosity UltraSound Gel6010026010022016-09-23
10815112020559E-Z-SCAN Low Viscosity UltraSound Gel6010036010032016-09-23
10815112020566E-Z-GEL UltraSound Gel6010046010042016-09-23
10815112021402E-Z-GEL UltraSound Gel6010016010012025-05-16
10815112021419E-Z-SCAN Low Viscosity UltraSound Gel6010026010022025-05-16
10815112021426E-Z-SCAN Low Viscosity UltraSound Gel6010036010032025-05-16
10815112021433E-Z-GEL UltraSound Gel6010046010042025-05-16
10815112020856"""Y"" Connector with Tubing"9004029004022016-09-19

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
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
14897106953797andorate® CO2 Extend Tubing with Luer ConnectorGA Health Company LimitedFCX2022-02-23