Disposable Hemodialysis Access Catheter Set Double

Primary DI
26938634490530
Brand
Disposable Hemodialysis Access Catheter Set Double
Company
Guangdong Baihe Medical Technology Co., Ltd.
Model
R6Z-FR-225915
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
16938634490533PackageGS110In Commercial Distribution
26938634490530PackageGS140In Commercial Distribution
06938634490536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693863449053316938634490533
2693863449053026938634490530
06938634490536069386344905366938634490536

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
547055364
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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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