V-Cath

Basic Information

• Brand Name: V-Cath
• Primary DI: B33940530030
• Version / Model: 4053-003
• Catalog Number: 4053-003
• Company Name: NEO MEDICAL INC.
• Labeler DUNS: 015510540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2019-06-07
• Public Version Status: Update
• Public Device Record Key: d8ddcb96-5f28-4829-9846-1bc66632db93

Device Description

4.0Fr x 10cm Tearaway Sheath Dilator Introducer Set

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: Yes
• MRI Safety: MR Safe
• 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
KZH	Introducer, Syringe Needle	General Hospital	880.6920	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58865	Vascular catheter introduction set, nonimplantable	A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B33940530035	HIBCC	Case	5	In Commercial Distribution
Primary	B33940530030	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K951384	000

Device Sizes

Type	Value	Unit	Text
Length	10.0	Centimeter
Catheter Gauge	4.0	French

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Away From Sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry