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
06936534343020Disposable Ureteral StentsMD-D-JC-6F-26-S2026-09-22
06942804744602Single Use Ureteral Access SheathMD-A-AS-11522026-09-22
06942804744619Single Use Ureteral Access SheathMD-A-AS-11532026-09-22
06942804744626Single Use Ureteral Access SheathMD-A-AS-11542026-09-22
06942804744633Single Use Ureteral Access SheathMD-A-AS-11552026-09-22
06942804744640Single Use Ureteral Access SheathMD-A-AS-10362026-09-22
06942804744657Single Use Ureteral Access SheathMD-A-AS-10372026-09-22
06942804744664Single Use Ureteral Access SheathMD-A-AS-10382026-09-22
06942804744671Single Use Ureteral Access SheathMD-A-AS-10392026-09-22
06942804744688Single Use Ureteral Access SheathMD-A-AS-10402026-09-22
06942804744695Single Use Ureteral Access SheathMD-A-AS-10412026-09-22
06942804744701Single Use Ureteral Access SheathMD-A-AS-10422026-09-22
06942804744718Single Use Ureteral Access SheathMD-A-AS-10432026-09-22
06942804744725Single Use Ureteral Access SheathMD-A-AS-10442026-09-22
06942804744732Single Use Ureteral Access SheathMD-A-AS-10462026-09-22
06942804744749Single Use Ureteral Access SheathMD-A-AS-10472026-09-22
06942804744756Single Use Ureteral Access SheathMD-A-AS-10482026-09-22
06942804744763Single Use Ureteral Access SheathMD-A-AS-10492026-09-22
06942804744770Single Use Ureteral Access SheathMD-A-AS-10502026-09-22
06942804744787Single Use Ureteral Access SheathMD-A-AS-10512026-09-22

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