Angel Catheter

Basic Information

• Brand Name: Angel Catheter
• Primary DI: B077AC3930A1
• Version / Model: AC3930A
• Company Name: BIO2 MEDICAL INC
• Labeler DUNS: 019935020
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 7
• Public Version Date: 2021-02-19
• Public Version Status: Update
• Public Device Record Key: de9ecea1-fcc3-481f-a0d1-efa506aa9031

Device Description

The Angel® Catheter combines the functions of a retrievable inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PNS	Short-Term Intravascular Filter Catheter	Cardiovascular	870.3375	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44864	Vena cava filter, temporary/permanent	A vascular device intended to be percutaneously implanted in the inferior vena cava (IVC) to prevent pulmonary embolism (PE); it can be retrieved before a threshold period or remain as a permanent implant after the period. It achieves its unconstrained diameter upon deployment in the IVC and imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. It is designed for blood clot capture while maintaining caval patency. It is made of metal alloys [e.g., stainless steel, titanium (Ti), nickel-titanium alloy (Nitinol)] and is available in various self-expanding designs (e.g., conical, basket). This is a single-use device.	Yes	Active
10729	Centrally-inserted central venous catheter	A flexible tube intended to be introduced into a neck or thoracic vein and often advanced into the superior vena cava for various infusion/aspiration procedures (i.e., non-dedicated) including the intravenous administration of nutrients, fluids, chemotherapeutic agents or other drugs, and blood sampling or delivery; it may also be used to monitor venous pressure. The proximal end of this central venous catheter (CVC) is typically fixed to the patient for long-term use. It may include supportive devices associated with introduction (e.g., guidewire, introducer); it is not primarily intended for extracorporeal blood therapies such as haemodialysis. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B077AC3930A1	HIBCC
Package	B077AC3930A5	HIBCC	Case	5	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]