AngioDynamics

Basic Information

• Brand Name: AngioDynamics
• Primary DI: H787065200010
• Version / Model: 06520001
• Company Name: ANGIODYNAMICS, INC.
• Labeler DUNS: 079105071
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 8
• Public Version Date: 2023-07-03
• Public Version Status: Update
• Public Device Record Key: 09382965-e14c-4720-a6cc-2f55409585f0

Device Description

Straight, Non-Coring, High-Flow Needle

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: Labeling does not contain MRI Safety Information
• 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
DRC	Trocar	Cardiovascular	870.1390	2
DQR	CANNULA, CATHETER	Cardiovascular	870.1300	2
DYB	INTRODUCER, CATHETER	Cardiovascular	870.1340	2
DQX	WIRE, GUIDE, CATHETER	Cardiovascular	870.1330	2
FMI	Needle, hypodermic, single lumen	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17701	Vascular port administration set	A collection of devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system via a previously implanted injection/infusion port. It typically includes a noncoring needle designed with a lateral hole (side-hole), tubing, connectors, chambers, clamps and may include an injection placement aid. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	H787065200015	HIBCC	BOX	10	In Commercial Distribution
Primary	H787065200010	HIBCC
Secondary	15051684011716	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K051655	000
K961088	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 27 Degrees Celsius