FDA.reportPublic FDA data

DORA

Primary DI
06948082700729
Brand
DORA
Company
Bain Medical Equipment (Guangzhou) Co., Ltd.
Model
BAIN-BL-002E
Published
2026-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16948082700726PackageGS124In Commercial Distribution
06948082700729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694808270072616948082700726
06948082700729069480827007296948082700729

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.

Regulatory Flags#

DUNS number
526972767
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
06948082753947DORABAIN-A.V.F-001ASE2026-05-13
06948082753954DORABAIN-A.V.F-001VSE2026-05-13
06948082770036NovaLine9560072024-07-31
16948082770033NovaLine9560072024-07-31
06948082746086DORABAIN-A.V.F-001SE2023-04-11
06948082746093DORABAIN-A.V.F-005SE2023-04-11
06948082746116DORABAIN-A.V.F-049SE2023-04-11
06948082749681DORABAIN-A.V.F-003SE2023-04-11
06948082749698DORABAIN-A.V.F-007SE2023-04-11
06948082749704DORABAIN-A.V.F-051SE2023-04-11
16948082746083DORABAIN-A.V.F-001SE2023-04-11
16948082746090DORABAIN-A.V.F-005SE2023-04-11
06948082746109DORABAIN-A.V.F-009SE2023-04-11
16948082746113DORABAIN-A.V.F-049SE2023-04-11
16948082749688DORABAIN-A.V.F-003SE2023-04-11
16948082749695DORABAIN-A.V.F-007SE2023-04-11
16948082749701DORABAIN-A.V.F-051SE2023-04-11
06948082746642DORABAIN-A.V.F-011SE2022-12-28
06948082746659DORABAIN-A.V.F-012SE2022-12-28
06948082709777NovaLineBL 422022-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
008408611026245008XFresenius 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