Angioway

GUDID 16936733735937

Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment (such as percutaneous coronary angioplasty, PTCA; stent Implantation operation) provides the pressure inside the balloon.

Lepu Medical Technology (Beijing) Co.,Ltd.

Catheter/overtube balloon inflator, single-use
Primary Device ID16936733735937
NIH Device Record Key358e524d-d12b-4ff3-b58c-56b3338efd54
Commercial Distribution StatusIn Commercial Distribution
Brand NameAngioway
Version Model NumberLP-P-30-YNP
Company DUNS529853921
Company NameLepu Medical Technology (Beijing) Co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106936733735930 [Primary]
GS116936733735937 [Package]
Contains: 06936733735930
Package: Box [5 Units]
In Commercial Distribution

FDA Product Code

PTLWire, Guide, Catheter, Exempt

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-05-06
Device Publish Date2018-05-23

On-Brand Devices [Angioway]

16936733736156Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment
16936733736149Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment
16936733736132Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment
16936733736125Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment
16936733736118Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment
16936733736101Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment
16936733736095Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment
16936733736088Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment
16936733736071Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment
16936733736064Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment
16936733736057Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment
16936733736040Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment
16936733736033Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment
16936733736026Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment
16936733736019Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment
16936733736002Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment
16936733735999Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment
16936733735982Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment
16936733735975Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment
16936733735968Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment
16936733735951Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment
16936733735944Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment
16936733735937Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment
16936733735920Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment
16936733735890The inflation device is applied to inflate/deflate balloon catheters and monitor pressure within
16936733735883The inflation device is applied to inflate/deflate balloon catheters and monitor pressure within

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