FDA.reportPublic FDA data

5008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (Tw

Primary DI
00840861102389
Brand
5008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (Tw
Company
Fresenius Medical Care Renal Therapies Group, LLC
Model
03-5150-2
Published
2024-04-08
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
FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve
KOCAccessories, Blood Circuit, Hemodialysis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FJKSet, Tubing, Blood, With And Without Anti-Regurgitation ValveGastroenterology, Urology2
KOCAccessories, Blood Circuit, HemodialysisGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231534000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2315340005008X Hemodialysis SystemFresenius Medical Care2024-02-02KDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840861102386PackageGS124In Commercial Distribution
00840861102389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084086110238610840861102386
00840861102389008408611023898408611023890840861102389

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
Special Storage Condition, Specify00Store at room temperature. Protect from moisture, freezing and excessive heat.

Contacts#

Phone, Email table
PhoneEmail
1 (800)323-5188xxx@xxx.xxx

Regulatory Flags#

DUNS number
079732391
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840861103010Acid connector cpl 10L jugF500449502025-08-01
00840861103027Acid connector guide 1 GalF500449532025-08-01
00840861103058BicarbyRFP-404-W2025-12-18
00840861103065BicarbyRFP-453-W2025-12-18
00840861103072BicarbyRFP-454-W2025-12-18
00840861103089BicarbyRFP-456-W2025-12-18
00840861103096BicarbyRFP-403-W2025-12-18
00840861103102BicarbyRFP-403-G2025-12-18
00840861103119BicarbyRFP-453-G2025-12-18
00840861103126BicarbyRFP-454-G2025-12-18
10840861103055BicarbyRFP-404-W2025-12-18
10840861103062BicarbyRFP-453-W2025-12-18
10840861103079BicarbyRFP-454-W2025-12-18
10840861103086BicarbyRFP-456-W2025-12-18
10840861103093BicarbyRFP-403-W2025-12-18
10840861103109BicarbyRFP-403-G2025-12-18
10840861103116BicarbyRFP-453-G2025-12-18
10840861103123BicarbyRFP-454-G2025-12-18
008408611024645008X Fluid Sampling Accessory04-9009-42024-04-08
008408611024335008X Hemodialysis MachineM2044412024-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06948082774904NovaLineBain Medical Equipment (Guangzhou) Co., Ltd.FJK2026-06-04
00842289103689System One Cycler BaseNXSTAGE MEDICAL, INC.KOC2026-04-22
00842289103696Extended Cycler Base and Filter HolderNXSTAGE MEDICAL, INC.KOC2026-04-22
00842289103702Fluid Detection SystemNXSTAGE MEDICAL, INC.KOC2026-04-22
008408611025185008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
008408611025255008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
008408611025325008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
008408611025565008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
008408611025635008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
008408611026005008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
008408611026245008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
00860008016942Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00860008016973Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00860008016904Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00860008016911Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00860008016928Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00860008016959Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00860008016966Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00383790011877SLIMLINE™ BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETNIPRO MEDICAL CORPORATIONFJK2025-06-01
00383790011884NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETNIPRO MEDICAL CORPORATIONFJK2025-06-01
00383790011891NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETNIPRO MEDICAL CORPORATIONFJK2025-06-01
00383790011907NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETNIPRO MEDICAL CORPORATIONFJK2025-06-01
008408611023655008X HDF Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLCFJK2024-04-08
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
008408611023725008X HDF Hemodialysis Blood Tubing Set with CLiC Blood ChamberFresenius Medical Care Renal Therapies Group, LLCFJK2024-04-08
008408611024645008X Fluid Sampling AccessoryFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
00840861102402CombiSetFresenius Medical Care Holdings, Inc.FJK2023-10-19
B144MPC825S0Molded Products, Inc.MOLDED PRODUCTS, INC.KOC2022-10-04
00850001011211Tablo(R) CartridgeOutset Medical, Inc.FJK2022-04-11