FDA.reportPublic FDA data

BLOOD TUBING LINES FOR HEMODIALYSIS

Primary DI
04987671201102
Brand
BLOOD TUBING LINES FOR HEMODIALYSIS
Company
NIKKISO CO.,LTD.
Model
AV06C-P
Device description
The BLOOD TUBING LINES FOR HEMODIALYS IS includes arterial and venous dialysis blood tubing. The devices are packaged together for convenient use during hemodialysis procedures.They are manufactured for application with the NIKKISO DBB-06 Hemodialysis Delivery System.
Published
2020-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KOCAccessories, Blood Circuit, Hemodialysis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOCAccessories, Blood Circuit, HemodialysisGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24987671201106PackageGS128In Commercial Distribution
04987671201102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2498767120110624987671201106
04987671201102049876712011024987671201102

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis blood tubing set, single-useA collection of tubing segments and associated devices (e.g., connectors, clamps) intended to be used to transfer blood between a patient's vascular access device and a haemodialyser during haemodialysis; it is sometimes referred to as haemodialysis blood lines. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+81334433727xx@xx.xx

Regulatory Flags#

DUNS number
690542378
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987671041517HEMODIALYSIS DELIVERY SYSTEMDBB-062015-09-29
04987671060006HEMODIALYSIS DELIVERY SYSTEMDBB-062016-08-12
04987671030214Filter for dialysate purificationEF-02D2025-04-07
04987671041708Hemodialysis Delivery SystemDBB-06 PRO2025-08-22
04987671100627Blood Tubing Lines for HemodialysisAL-CDC-E(U)2025-08-22
24987671041702Hemodialysis Delivery SystemDBB-06 PRO2025-08-22
24987671100621Blood Tubing Lines for HemodialysisAL-CDC-E(U)2025-08-22
04987671100658Blood Tubing Lines for HemodialysisC18SFD-E(U)2025-08-22
24987671030218Filter for dialysate purificationEF-02D2025-04-07
04987671400000Blood Tubing Lines for HemodialysisAV06C-E2023-08-28
24987671201106BLOOD TUBING LINES FOR HEMODIALYSISAV06C-P2020-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842289103689System One Cycler BaseNXSTAGE MEDICAL, INC.KOC2026-04-22
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00842289103702Fluid Detection SystemNXSTAGE MEDICAL, INC.KOC2026-04-22
04987671100627Blood Tubing Lines for HemodialysisNIKKISO CO.,LTD.KOC2025-08-22
24987671100621Blood Tubing Lines for HemodialysisNIKKISO CO.,LTD.KOC2025-08-22
04987671100658Blood Tubing Lines for HemodialysisNIKKISO CO.,LTD.KOC2025-08-22
008408611023655008X HDF Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
008408611023725008X HDF Hemodialysis Blood Tubing Set with CLiC Blood ChamberFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
008408611023895008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (TwFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
008408611024645008X Fluid Sampling AccessoryFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
108408611023625008X HDF Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
108408611023795008X HDF Hemodialysis Blood Tubing Set with CLiC Blood ChamberFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
108408611023865008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (TwFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
108408611024615008X Fluid Sampling AccessoryFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
04987671400000Blood Tubing Lines for HemodialysisNIKKISO CO.,LTD.KOC2023-08-28
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