Sunmed High Pressure Line

GUDID 06947358520405

Sunny Medical Device (Shenzhen) Co., Ltd.

Cardiopulmonary bypass system pressure-monitoring tubing Cardiopulmonary bypass system pressure-monitoring tubing Cardiopulmonary bypass system pressure-monitoring tubing Cardiopulmonary bypass system pressure-monitoring tubing Cardiopulmonary bypass system pressure-monitoring tubing Cardiopulmonary bypass system pressure-monitoring tubing Cardiopulmonary bypass system pressure-monitoring tubing Cardiopulmonary bypass system pressure-monitoring tubing Cardiopulmonary bypass system pressure-monitoring tubing Cardiopulmonary bypass system pressure-monitoring tubing Cardiopulmonary bypass system pressure-monitoring tubing Cardiopulmonary bypass system pressure-monitoring tubing Cardiopulmonary bypass system pressure-monitoring tubing Cardiopulmonary bypass system pressure-monitoring tubing Cardiopulmonary bypass system pressure-monitoring tubing Cardiopulmonary bypass system pressure-monitoring tubing Cardiopulmonary bypass system pressure-monitoring tubing
Primary Device ID06947358520405
NIH Device Record Key5de1bf72-e31b-4ccf-9a99-6e18e6a6e4f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSunmed High Pressure Line
Version Model Number400psi, 15cm
Company DUNS529639795
Company NameSunny Medical Device (Shenzhen) Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106947358520405 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQOCatheter, Intravascular, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-23
Device Publish Date2020-04-15

Devices Manufactured by Sunny Medical Device (Shenzhen) Co., Ltd.

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06947358582618 - Sunmed disposable angio-closure pads2023-07-14
06947358544302 - Sunmed guidewire torque device2022-01-12
06947358566007 - Sunmed Inflation Device2022-01-12
06947358568001 - Sunmed Inflation Device2022-01-12

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