FDA.reportPublic FDA data

5008X HDF Hemodialysis Blood Tubing Set

Primary DI
00840861102365
Brand
5008X HDF Hemodialysis Blood Tubing Set
Company
Fresenius Medical Care Renal Therapies Group, LLC
Model
03-5100-7
Published
2024-04-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10840861102362PackageGS124Not in Commercial Distribution
00840861102365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084086110236210840861102362
00840861102365008408611023658408611023650840861102365

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
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008408611023725008X HDF Hemodialysis Blood Tubing Set with CLiC Blood Chamber03-5100-7C2024-04-08
008408611023895008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (Tw03-5150-22024-04-08
00840861102396CitraSure™28-0600-02024-04-04
008408611026245008X04-3000-92025-08-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09555793100891VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100907VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100921VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100938VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100945VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100969VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100976VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100983VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100990VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793101003VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107524VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107531VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107548VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107555VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107562VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107579VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107586VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107593VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107609VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
08859915300024N/ATIANYI MEDICAL(THAILAND) LIMITEDFJK2026-08-03
09555793100914VITALVITAL HEALTHCARE SDN. BHD.FJK2026-07-24
09555793100952VITALVITAL HEALTHCARE SDN. BHD.FJK2026-07-24
09555793102284VITALVITAL HEALTHCARE SDN. BHD.FJK2026-07-24
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