Angioway

GUDID 16936733735975

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 ID: 16936733735975
• NIH Device Record Key: 935df948-caca-4089-9687-cb730bfc0868
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Angioway
• Version Model Number: LP-P-30-YNP50
• Company DUNS: 529853921
• Company Name: Lepu Medical Technology (Beijing) Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06936733735978 [Primary]
GS1	16936733735975 [Package]; Contains: 06936733735978; Package: Box [5 Units]; In Commercial Distribution

FDA Product Code

• PTM: Syringe, Balloon Inflation, Exempt

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-05-06
• Device Publish Date: 2018-05-23

On-Brand Devices [Angioway]

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