FDA.reportPublic FDA data

CO2 Source Tubing

Primary DI
06936534332246
Brand
CO2 Source Tubing
Company
Zhejiang Chuangxiang Medical Technology Co., LTD.
Model
MD-A-TS-2100
Published
2023-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K231471000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231471000Air/Water Bottle Tubing, CO2 Source TubingZhejiang Chuangxiang Medical Technology Co., Ltd.2023-09-08OCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06936534332246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936534332246069365343322466936534332246

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544434963
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970401812110Single Use Grasping ForcepsMD-C-GF18062023-02-07
06970401813490Single Use GuidewireMD-S-GW35452019-03-23
06970401813766Single Use GuidewireMD-A-GW35452021-09-27
06970401815661Single Use GuidewireMD-S-GW25452020-06-17
06936534325439Single Use Urinary GuidewireMD-A1-UW21182023-11-27
06936534325446Single Use Urinary GuidewireMD-A1-UW21202023-11-27
06936534325453Single Use Urinary GuidewireMD-A1-UW21262023-11-27
06936534325460Single Use Urinary GuidewireMD-A1-UW25052023-11-27
06936534325477Single Use Urinary GuidewireMD-A1-UW25102023-11-27
06936534325484Single Use Urinary GuidewireMD-A1-UW25122023-11-27
06936534325491Single Use Urinary GuidewireMD-A1-UW25152023-11-27
06936534325507Single Use Urinary GuidewireMD-A1-UW25182023-11-27
06936534325514Single Use Urinary GuidewireMD-A1-UW25202023-11-27
06936534325521Single Use Urinary GuidewireMD-A1-UW25262023-11-27
06936534325538Single Use Urinary GuidewireMD-A1-UW28052023-11-27
06936534325545Single Use Urinary GuidewireMD-A1-UW28102023-11-27
06936534325552Single Use Urinary GuidewireMD-A1-UW28122023-11-27
06936534325569Single Use Urinary GuidewireMD-A1-UW28152023-11-27
06936534325576Single Use Urinary GuidewireMD-A1-UW28182023-11-27
06936534325583Single Use Urinary GuidewireMD-A1-UW28202023-11-27

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