FDA.reportPublic FDA data

Angioway

Primary DI
06936733735947
Brand
Angioway
Company
Lepu Medical Technology (Beijing) Co.,Ltd.
Model
LP-P-30-YNP20
Device description
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.
Published
2018-05-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
PTLWire, Guide, Catheter, Exempt
PTMSyringe, Balloon Inflation, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassCardiovascular2
PTLWire, Guide, Catheter, ExemptCardiovascular2
PTMSyringe, Balloon Inflation, ExemptCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16936733735944PackageGS15In Commercial Distribution
06936733735947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693673373594416936733735944
06936733735947069367337359476936733735947

GMDN Terms#

Term, Definition table
TermDefinition
Catheter/overtube balloon inflator, single-useA device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.

Regulatory Flags#

DUNS number
529853921
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936733738191BrilliantACS0524212026-04-16
06936733738207BrilliantACS0607212026-04-16
06936733738214BrilliantACS0624212026-04-16
06936733738221BrilliantACS0607352026-04-16
06936733738238BrilliantACS0611352026-04-16
06936733738245BrilliantACS0616352026-04-16
06936733738252BrilliantACS0624352026-04-16
06936733738276BrilliantACS0711352026-04-16
06936733738283BrilliantACS0716352026-04-16
06936733738290BrilliantACS0724352026-04-16
06936733738306BrilliantRSC0407212026-04-16
06936733738313BrilliantRSC040721A2026-04-16
06936733738320BrilliantRSC0407252026-04-16
06936733738337BrilliantRSC0411212026-04-16
06936733738344BrilliantRSC041121A2026-04-16
06936733738351BrilliantRSC0411252026-04-16
06936733738368BrilliantRSC0416212026-04-16
06936733738375BrilliantRSC041621A2026-04-16
06936733738382BrilliantRSC0416252026-04-16
06936733738399BrilliantRSC0424212026-04-16

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Primary DI, Brand, Company table
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