EpiAccess Needle

Basic Information

• Brand Name: EpiAccess Needle
• Primary DI: B3000399139500
• Version / Model: 0399-13950
• Company Name: EPIEP, INC.
• Labeler DUNS: 965279909
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: cff284a2-7ce5-471c-90f1-ea0b8dd545ae

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
DYB	Introducer, Catheter	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44135	Pericardiocentesis needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument specifically designed for the puncture of the pericardial cavity for the aspiration (removal) of fluids (pericardiocentesis). The device is typically long and rigid enough to penetrate the pericardium (e.g., 10 to 18 centimetres in length). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B3000399139500	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K142245	000