NC70000T

Basic Information

• Brand Name: NC70000T
• Primary DI: 10816336022121
• Version / Model: NC70000T
• Company Name: NEOCHILD, LLC
• Labeler DUNS: 022760922
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-01
• Public Version: 2
• Public Version Date: 2019-09-19
• Public Version Status: Update
• Public Device Record Key: e24723a6-49f4-4272-aa9c-0e41a40802ae

Device Description

IV Insertion Kit

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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRO	General Surgery Tray	General, Plastic Surgery	878.4370	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	20816336022128	GS1		20	Not in Commercial Distribution	2019-09-18
Primary	10816336022121	GS1
Package	30816336022125	GS1	Case	50	In Commercial Distribution