FDA.reportPublic FDA data

Disposable Hemodialysis Access Catheter Set Double Lumen8.5F*10cm(Cruved)

Primary DI
06938634490468
Brand
Disposable Hemodialysis Access Catheter Set Double Lumen8.5F*10cm(Cruved)
Company
Guangdong Baihe Medical Technology Co., Ltd.
Model
R1W-FR-2913
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MPBCatheter, Hemodialysis, Non-Implanted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPBCatheter, Hemodialysis, Non-ImplantedGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102833000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102833000DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETSFoshan Nanhai Bai HE Medical Technology Co., Ltd.2011-11-18MPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16938634490465PackageGS110In Commercial Distribution
26938634490462PackageGS140In Commercial Distribution
06938634490468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693863449046516938634490465
2693863449046226938634490462
06938634490468069386344904686938634490468

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis catheterization kitA collection of sterile devices and materials intended to be used for short-term (< 30 days) venous access during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It includes a nonimplantable double-lumen haemodialysis catheter, device dedicated to catheter introduction/function (e.g., introducer needle, guidewire) and includes non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.

Regulatory Flags#

DUNS number
547055364
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06938634454309Disposable Hemodialysis Access Catheter Set Single Lumen8F*10cmFH-18132016-09-22
06938634454422Disposable Hemodialysis Access Catheter Set Single Lumen7F*10cmFH-17132016-09-22
06938634460133ABLE CENTRAL VENOUS CATHETERTriple Lumen 7F*30cmFV-37282016-09-22
06938634460171ABLE CENTRAL VENOUS CATHETERTriple Lumen 7F*13cmFC-37242016-09-22
06938634461857ABLE CENTRAL VENOUS CATHETERDouble Lumen 5F*10cmFC-25232016-09-22
06938634463035ABLE CENTRAL VENOUS CATHETERDouble Lumen 7F*10cmFV-27232016-09-20
06938634463196ABLE CENTRAL VENOUS CATHETERSingle Lumen 16G*10cmFV-15232016-09-22
06938634469624Disposable Hemodialysis Access Catheter Set Double Lumen 14F*20cmFR-24162016-09-20
06938634469662Disposable Hemodialysis Access Catheter Set Double Lumen14F*16cmFR-24152016-09-20
06938634469709Disposable Hemodialysis Access Catheter Set Double Lumen 14F*15cmFR-2419152016-09-20
06938634469815Disposable Hemodialysis Access Catheter Set Double Lumen12F*20cmFR-22562016-09-22
06938634469891Disposable Hemodialysis Access Catheter Set Double Lumen12F*16cmFR-22552016-09-22
06938634469938Disposable Hemodialysis Access Catheter Set Double Lumen12F*15cmFR-2259152016-09-22
06938634469976Disposable Hemodialysis Access Catheter Set Double Lumen12F*13cmFR-22542016-09-22
06938634469983Disposable Hemodialysis Access Catheter Set Double Lumen12F*13cmFR-22142016-09-20
06938634470491Disposable Hemodialysis Access Catheter Set Double Lumen 11.5F*20cmFR-21162016-09-22
06938634470514Disposable Hemodialysis Access Catheter Set Double Lumen11.5F*20cmFH-21162016-09-22
06938634470583Disposable Hemodialysis Access Catheter Set Double Lumen11.5F*16cmFH-21552016-09-22
06938634470590Disposable Hemodialysis Access Catheter Set Double Lumen11.5F*16cmFH-21152016-09-22
06938634470613Disposable Hemodialysis Access Catheter Set Double Lumen11.5F*15cmFR-2119152016-09-22

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