NEOMED*

Basic Information

• Brand Name: NEOMED*
• Primary DI: 00350770003337
• Version / Model: LK2215
• Catalog Number: LK2215
• Company Name: Avanos Medical, Inc.
• Labeler DUNS: 079375431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-27
• Public Version: 1
• Public Version Date: 2021-09-06
• Public Version Status: New
• Public Device Record Key: a9bc9846-88a0-4a84-8276-2b7bddb636db

Device Description

LK2215 Lumbar Puncture Tray 22G x 1.5 Needle

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PWY	Lumbar puncture tray (adult & pediatric)	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12404	Lumbar puncture kit	A collection of sterile devices designed to perform a puncture of the lumbar spine to obtain spinal fluid. Typical components include a spinal needle and collection tubes for spinal fluid. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10350770003334	GS1	CS	5	In Commercial Distribution
Primary	00350770003337	GS1

Customer Contacts

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