NeoMagic

Basic Information

• Brand Name: NeoMagic
• Primary DI: B33919770010
• Version / Model: 1977-001
• Catalog Number: 1977-001
• Company Name: Neo Medical Inc.
• Labeler DUNS: 015510540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-27
• Public Version: 1
• Public Version Date: 2026-04-06
• Public Version Status: New
• Public Device Record Key: f6c50fd7-9bb1-43ea-b70c-720fb16b6b2f

Device Description

Catheter Trimmer

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
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61345	Vascular catheterization support/maintenance kit, non-medicated	A collection of non-dedicated devices intended for catheterization support and/or catheter maintenance (e.g., dressing change, catheter flushing) associated with peripheral venous, central venous, and/or arterial catheterization. Primarily intended to be used at the patient’s bedside, the kit includes devices such as: personal protective equipment (PPE), drapes, disinfectant wipes, dressings, needles, syringes, forceps, scissors, scalpel, tourniquets, ultrasound transducer cover, coupling gel, sharps container, and saline solution. Neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B33919770010	HIBCC
Package	B33919770015	HIBCC	Case	10	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K983916	000

Storage Conditions

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