Tian Medical

Basic Information

• Brand Name: Tian Medical
• Primary DI: 00864915000308
• Version / Model: Tx360
• Company Name: Tian Medical, LLC
• Labeler DUNS: 070075971
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-18
• Public Version: 2
• Public Version Date: 2021-06-09
• Public Version Status: Update
• Public Device Record Key: da9d3ea5-8606-4008-9e3d-a07c6b95e7d5

Device Description

Tx360™ Nasal Applicator

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: 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
EPN	Pump, Nebulizer, Manual	Ear, Nose, Throat	874.5220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45332	Nasopharyngeal medicine administration kit	A collection of devices intended to be used to deliver an accurate dosage of medication, typically a local anaesthetic for an ear/nose/throat (ENT) procedure, into the nasal cavity and pharyngeal areas. It will typically include a medicine dispenser (i.e., a dedicated atomizing nozzle), a pump that allows delivery of a discrete volume of medication, and the medication in an appropriate container. This is a reusable device; the atomizer, however, is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00864915000308	GS1
Package	00864915000315	GS1	Inner Pack	10	In Commercial Distribution