Sunmed High Pressure Line

Primary DI
06947358520405
Brand
Sunmed High Pressure Line
Company
Sunny Medical Device (Shenzhen) Co., Ltd.
Model
400psi, 15cm
Published
2020-04-15
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
DQOCatheter, Intravascular, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140356000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140356000SUMMED HIGH PRESSURE LINESunny Medical Device (Shenzhen) Co., Ltd.2015-03-20DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06947358520405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06947358520405069473585204056947358520405

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system pressure-monitoring tubingA sterile length of flexible tube intended to interface a pressure monitor/manometer with a cardiopulmonary bypass system to allow fluid pressure to be measured; connectors are typically included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529639795
Device count
1
Lot or batch
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
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06947358535539Sunmed™ guide wires"S-tip, 0.035""x145cm, Hydrophilic Coated"2024-01-05
06947358563402Sunmed Inflation devicesS-type, 30ml, 40atm/bar2023-09-25
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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
06947358551904Sunmed Manifold and Stopcocks500psi, off hand2020-04-15
06947358563006Sunmed Inflation Device30atm, 30ml2020-04-15
06947358500001Sunmed Protective face shield340mm×220mm2020-08-22

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