FDA.reportPublic FDA data

MINDRAY

Primary DI
06972620113009
Brand
MINDRAY
Company
BQ PLUS MEDICAL CO., LTD.
Model
S-TS-000D
Published
2023-12-31
Public version status
Update
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
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210381000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210381000I.V. Administration SetBq Plus Medical Co., Ltd.2021-08-14FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972620113009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972620113009069726201130096972620113009

GMDN Terms#

Term, Definition table
TermDefinition
Blood transfusion set, non-exchangeAn intravascular administration set intended to be used to administer blood from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device typically includes a needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, a stopcock, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an intravenous (IV) bag or other infusion fluid container. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544463583
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850067227110NEW PENTASTAR MEDICAL12762026-03-30
00369771001303Gerimedix112212026-03-30
00369771001310Gerimedix112212026-03-30
00810110920972IMSIM420312026-03-30
00850067227113NEW PENTASTAR MEDICAL12762026-03-30
00853155008045IMSIM410002026-03-30
00853155008052IMSIM410012026-03-30
00853155008069IMSIM410022026-03-30
00853155008281IMSIM410182026-03-30
00853155008816IMSIM420712026-03-30
00853155008823IMSIM420722026-03-30
00853155008830IMSIM420732026-03-30
00853155008847IMSIM420742026-03-30
00853155008861IMSIM420762026-03-30
00853620005777MERITMERISET0162026-03-30
00853620005951MERITMHI1000B2026-03-30
06972620114112McGuff0032002026-03-30
06972620114877MERITEX004B2026-03-30
06972620112347Right Way MedicalRWM-IFRF012025-03-21
16972620112351Right Way MedicalRWM-IFRF012025-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10813153028329CodanCodan US CorporationFPA2026-07-17
00827989008243MedSafetyHealth Care Logistics, Inc.FPA2026-07-10
05051684018473LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018480LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018497LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018503LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018510LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018527LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018534LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018541LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018558LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018565LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018572LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018589LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018596LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018602LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018619LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018626LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018633LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018640LifeguardAngiodynamics, Inc.FPA2026-06-23
00811505030573IvenixFresenius Kabi AGFPA2026-06-02
04046955836383Infusomat®B. BRAUN MEDICAL INC.FPA2024-08-15
04046955836406Infusomat®B. BRAUN MEDICAL INC.FPA2024-08-15
00382905168031BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
00382905168000BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
00085412676630DUO-VENTBAXTER HEALTHCARE CORPORATIONFPA2023-07-11
00634624911109Precision Delivery Bifurcated IV Extension SetQUEST MEDICAL INCFPA2022-12-19
00634624911048High-Flow Extension SetQUEST MEDICAL INCFPA2022-12-12
00634624101159Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06