Epimed International, Inc.

Basic Information

• Brand Name: Epimed International, Inc.
• Primary DI: 00818788023698
• Version / Model: 138-1427
• Catalog Number: 138-1427
• Company Name: EPIMED INTERNATIONAL, INC
• Labeler DUNS: 799751953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-05
• Public Version: 1
• Public Version Date: 2022-05-13
• Public Version Status: New
• Public Device Record Key: 29852c02-83f6-41be-8c4d-ad92d57526de

Device Description

Percutaneous Introducer w/ 14g RW x 2.75" B Bevel needle with sidearm injection port and hemostasis valve

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• 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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MIA	NEEDLE, SPINAL, SHORT TERM	Anesthesiology	868.5150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62391	Non-vascular catheter introduction set	A collection of sterile, invasive devices intended to enable percutaneous Seldinger-type introduction of a non-vascular catheter (e.g., drainage catheter) into a body cavity or lumen (e.g., biliary tract, ureter); it is not intended for introduction of a peritoneal dialysis catheter. It includes multiple invasive access devices which typically include an introducer needle, introducer sheath with an inner dilator, and guidewire; the catheter is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10818788023695	GS1	Case	10	In Commercial Distribution
Primary	00818788023698	GS1

Premarket Submissions

Submission Number	Supplement Number
K051860	000

Device Sizes

Type	Value	Unit	Text
Length	2.75	Inch
Device Size Text, specify			14g
Needle Gauge	14	Gauge
Device Size Text, specify			2.75in

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 50 – 90 Degrees Fahrenheit