FDA.reportPublic FDA data

NA

Primary DI
00816765013137
Brand
NA
Company
US Endoscopy
Model
710425
Catalog number
710425
Device description
The CO2 Endoscopic Insufflator Inline Tubing Set is intended to connect a CO2 source (insufflator) and a sterile water source (water bottle) to an endoscope to supply CO2 during gastrointestinal endoscopic procedures.
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
Sterile
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123047000BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SETBracco Diagnostic, Inc.2013-08-06FCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816765013134PackageGS124Not in Commercial Distribution
00816765013137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081676501313410816765013134
00816765013137008167650131378167650131370816765013137

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic insufflation tubing set, single-useA collection of flexible tubing intended to channel medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
627879687
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10724995184015Endo-Boot00711621007116212020-04-01
10724995184022Endo-Boot00711622007116222020-04-01
00724995190637ProArmor00711623007116232020-07-16
00724995190644ProArmor00711624007116242020-07-16
00724995180355NA3905133905132020-04-02
00724995180362CO2MPACT7103007103002020-04-02
00724995180386NA7103047103042020-04-02
00724995180409NA7104247104242020-04-02
00724995180416NA7104257104252020-04-02
00724995180423NA7104267104262020-04-02
00724995180430NA7106027106022020-04-02
00724995180447NA7106037106032020-04-02
00724995180454NA7106047106042020-04-02
00724995180522Torrent00711579007115792020-04-01
00724995180768UltramatrixUSBOLUSBOL2020-04-02
00724995180775UltramatrixUSBORUSBOR2020-04-02
00724995180782iSnare00711084007110842020-03-19
00724995180843Articulator00711804007118042020-04-01
00724995182472Short Throw00711018007110182020-03-19
00724995182489Short Throw00711019007110192020-03-19

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
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