FDA.reportPublic FDA data

Sunmed Haemostatic Valves

Primary DI
06947358546719
Brand
Sunmed Haemostatic Valves
Company
Sunny Medical Device (Shenzhen) Co., Ltd.
Model
7F, Push-pull, Sideon Tubing and Stopcock, Inserti
Published
2023-07-06
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
DQXWire, Guide, Catheter
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06947358546719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06947358546719069473585467196947358546719

GMDN Terms#

Term, Definition table
TermDefinition
Haemostasis valveA noninvasive device designed as a conduit through which a small-diameter diagnostic/interventional device(s) can be introduced into or withdrawn from a patient's vasculature while preventing backflow of blood; it might in addition be intended for urinary applications. It is intended to be attached, typically via Luer-lock, to an invasively-placed catheter introducer (not included) and typically has a self-sealing lumen(s) [e.g., Touhy-Borst valve] and sideport for the introduction of solutions. It may include noninvasive guidewire accessories (e.g., guidewire introducer). It is not designed to be connected between tubing (i.e., not an in-line valve). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529639795
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
06947358524021Sunmed™ guide wiresJ-tip, 0.035"x200cm, PTFE Coated2026-07-07
06947358535454Sunmed™ guide wiresJ-tip, 0.035"x145cm, PTFE Coated2026-07-07
06947358535539Sunmed™ guide wires"S-tip, 0.035""x145cm, Hydrophilic Coated"2024-01-05
06947358563402Sunmed Inflation devicesS-type, 30ml, 40atm/bar2023-09-25
06947358571698Sunmed disposable needles18G, Ultra-thin Wall, 7cm, Large Hub2023-07-06
06947358582618Sunmed disposable angio-closure padsLarge Size2023-07-06
06947358544302Sunmed guidewire torque deviceplastic type, white2022-01-04
06947358566007Sunmed Inflation DeviceJ Type, 28ml, 30atm/bar2022-01-04
06947358568001Sunmed Inflation DeviceJ Type, 28ml, 40atm/bar2022-01-04
06947358535317Sunmed Guide WiresJ tip, 0.035in, 175cm2021-12-13
06947358535508Sunmed Guide WiresS tip, 0.035in, 145cm2021-12-13
06947358535713Sunmed Guide WiresJ tip, 0.035in, 150cm2021-12-13
06947358535751Sunmed Guide WiresS tip, 0.035in, 150cm2021-12-13
06947358535812Sunmed Guide WiresJ tip, 0.035in, 260cm2021-12-13
06947358535843Sunmed Guide WiresS tip, 0.035in, 260cm2021-12-13
06947358561507Sunmed Inflation Device20ml, 30atm2021-06-01
06947358520405Sunmed High Pressure Line400psi, 15cm2020-04-15
06947358551904Sunmed Manifold and Stopcocks500psi, off hand2020-04-15
06947358563006Sunmed Inflation Device30atm, 30ml2020-04-15
06947358500001Sunmed Protective face shield340mm×220mm2020-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902206241ARROWTELEFLEX INCORPORATEDDQX2026-08-03
10801902192230ARROWTELEFLEX INCORPORATEDDQX2026-08-01
04547327167215CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167222CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167239CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167246CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167253CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167260CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
10801902190908ARROWTELEFLEX INCORPORATEDDQX2026-07-30
10801902198461ARROWTELEFLEX INCORPORATEDDQX2026-07-30
10705032057004AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057011AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057028AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057035AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057042AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057059AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057066AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057073AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057080AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10801902193237ARROWTELEFLEX INCORPORATEDDQX2026-07-29
10801902193244ARROWTELEFLEX INCORPORATEDDQX2026-07-29
10801902195101ARROWTELEFLEX INCORPORATEDDQX2026-07-29
10801902193251ARROWTELEFLEX INCORPORATEDDQX2026-07-27
10801902193268ARROWTELEFLEX INCORPORATEDDQX2026-07-27
10801902193275ARROWTELEFLEX INCORPORATEDDQX2026-07-27
10801902222357ARROWTELEFLEX INCORPORATEDDQX2026-07-27
04260461060036EMERYGLIDENano4Imaging GmbHDQX2026-07-23
00884450795705Merit Medical®Merit Medical Systems, Inc.DTL2026-07-21
07290015107426Drivewire 35 GuidewireRAPID MEDICAL LTDDQX2026-07-20
06936733736951ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-07-10