FDA.reportPublic FDA data

STREAMLINE

Primary DI
09551032478004
Brand
STREAMLINE
Company
VITAL HEALTHCARE SDN. BHD.
Model
BLU019E
Device description
Tubing Sets for Hemodialysis
Published
2026-10-23
Public version status
Update
Distribution status
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251341000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251341000VITAL Tubing Sets for HemodialysisVital Healthcare Sdn. Bhd.2026-01-16FJK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19551032478001PackageGS132In Commercial Distribution
09551032478004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1955103247800119551032478001
09551032478004095510324780049551032478004

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
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+60333962329general@vital.com.my

Regulatory Flags#

DUNS number
865809508
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 From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09551032478011STREAMLINEBLU020E2026-10-23
09555793107616VITALBLU023E2026-10-27
09555793100891VITALBLU002E2026-10-23
09555793100907VITALBLU003E2026-10-23
09555793100921VITALBLU005E2026-10-23
09555793100938VITALBLU006E2026-10-23
09555793100945VITALBLU007E2026-10-23
09555793100969VITALBLU009E2026-10-23
09555793100976VITALBLU010E2026-10-23
09555793100983VITALBLU011E2026-10-23
09555793100990VITALBLU012E2026-10-23
09555793101003VITALBLU013E2026-10-23
09555793107524VITALBLU014E2026-10-23
09555793107531VITALBLU015E2026-10-23
09555793107548VITALBLU016E2026-10-23
09555793107555VITALBLU017E2026-10-23
09555793107562VITALBLU018E2026-10-23
09555793107579VITALBLU019E2026-10-23
09555793107586VITALBLU020E2026-10-23
09555793107593VITALBLU021E2026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09555793107616VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-27
09551032478011STREAMLINEVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
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
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