FDA.report

N/A

Primary DI
08859915300017
Brand
N/A
Company
TIANYI MEDICAL(THAILAND) LIMITED
Model
TY-NDEO-A1
Catalog number
TY-NDEO-A1
Device description
Extracorporeal Blood Tubing Set
Published
2026-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve

Product Code Classifications

CodeDeviceSpecialtyClass
FJKSet, Tubing, Blood, With And Without Anti-Regurgitation ValveGastroenterology, Urology2

Premarket Submissions

SubmissionSupplement
K251442000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K251442000TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)Ningbo Tianyi Medical Appliance Co., Ltd.2025-10-02FJK

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
18859915300014PackageGS130In Commercial Distribution
08859915300017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1885991530001418859915300014
08859915300017088599153000178859915300017

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
661490333
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices Sharing Product Codes

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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
40383790011875SLIMLINE™ BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETNIPRO MEDICAL CORPORATIONFJK2025-06-01
40383790011882NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETNIPRO MEDICAL CORPORATIONFJK2025-06-01
40383790011899NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETNIPRO MEDICAL CORPORATIONFJK2025-06-01
40383790011905NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETNIPRO MEDICAL CORPORATIONFJK2025-06-01
00850001011259Tablo(R) CartridgeOUTSET MEDICAL, INC.FJK2024-05-21
00850001011273Tablo(R) CartridgeOUTSET MEDICAL, INC.FJK2024-01-22
10840861102409CombiSetFresenius Medical Care Holdings, Inc.FJK2023-10-19
04046955776016Hemodialysis BloodlinesB. BRAUN MEDICAL INC.FJK2023-03-06
10850001011218Tablo(R) CartridgeOutset Medical, Inc.FJK2022-04-11
00850001011242Tablo(R) CartridgeOutset Medical, Inc.FJK2022-04-11
16948082709774NovaLineBain Medical Equipment (Guangzhou) Co., Ltd.FJK2022-01-01
16948082709781NovaLineBain Medical Equipment (Guangzhou) Co., Ltd.FJK2022-01-01
10887709021980ICU MedicalICU MEDICAL, INC.FJK2021-08-29
10887709027517ICU MedicalICU MEDICAL, INC.FJK2021-08-29
10887709076409ICU MedicalICU MEDICAL, INC.FJK2021-08-29
10887709028019ICU MedicalICU MEDICAL, INC.FJK2021-07-27
04046955735280Hemodialysis BloodlinesB. BRAUN MEDICAL INC.FJK2021-07-25
05060497260016SC+ Haemodialysis SystemQUANTA DIALYSIS TECHNOLOGIES LIMITEDFJK2021-06-21
05060497260030SC+ Haemodialysis SystemQUANTA DIALYSIS TECHNOLOGIES LIMITEDFJK2021-06-21
37332414004096BLOOD CIRCUIT SETBAXTER HEALTHCARE CORPORATIONFJK2021-05-13
16948082702102NovaLineBain Medical Equipment (Guangzhou) Co., Ltd.FJK2021-03-15
16948082702119NovaLineBain Medical Equipment (Guangzhou) Co., Ltd.FJK2021-03-15
04046955348893Hemodialysis BloodlinesB. BRAUN MEDICAL INC.FJK2020-08-21