FDA.reportPublic FDA data

5008X

Primary DI
00840861102624
Brand
5008X
Company
Fresenius Medical Care Renal Therapies Group, LLC
Model
04-3000-9
Device description
5008X HD/HDF Medication Line
Published
2025-08-01
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243505000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2435050005008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC2025-05-30KDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840861102621PackageGS1200In Commercial Distribution
00840861102624PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084086110262110840861102621
00840861102624008408611026248408611026240840861102624

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) 227-2572xx@xx.xx

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
06948082700729DORABain Medical Equipment (Guangzhou) Co., Ltd.FJK2026-05-13
04711552764666SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-24
04711552760026SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23
04711552761498SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23
04711552764048SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23
04711552764086SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23
04711552764758SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23
08859915300017N/ATIANYI MEDICAL(THAILAND) LIMITEDFJK2026-01-01
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
108408611025155008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611025225008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611025395008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611025535008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611025605008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611026075008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611026215008XFresenius 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