NeoMagic

Basic Information

• Brand Name: NeoMagic
• Primary DI: B339194616080
• Version / Model: 1946-1608
• Catalog Number: 1946-1608
• Company Name: NEO MEDICAL INC.
• Labeler DUNS: 015510540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-11
• Public Version: 3
• Public Version Date: 2023-08-02
• Public Version Status: Update
• Public Device Record Key: a55cb9fc-2f78-46df-a3ca-3e0c10aa62f1

Device Description

1.9Fr x 8cm Single Lumen Polyurethane EPIV with Stylet (Catheter Only)

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 Conditional
• 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
64573	Peripheral intravenous catheterization kit	A collection of devices intended for the introduction of an included peripheral vein cannula, often referred to as a catheter, to enable short-term (= 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. In addition to the cannula, it includes non-dedicated devices intended to support the procedure [e.g., tourniquet, swabs, dressings, disinfectants (e.g., alcohol), tape, gloves]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B339194616085	HIBCC	Case	20	In Commercial Distribution
Primary	B339194616080	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K983916	000

Device Sizes

Type	Value	Unit	Text
Catheter Length	8	Centimeter
Catheter Gauge	1.9	French

Storage Conditions

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