ToTXinCare

Basic Information

• Brand Name: ToTXinCare
• Primary DI: 06978579510074
• Version / Model: TX-MV1041-7
• Company Name: Tongxin Home Care Industry (Shenzhen) Co., Limited
• Labeler DUNS: 620114188
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-11
• Public Version: 1
• Public Version Date: 2025-07-21
• Public Version Status: New
• Public Device Record Key: b26dd1d2-08ad-44ab-b798-74685c03eeba

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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
JPW	Pump, Nebulizer, Electrically Powered	Ear, Nose, Throat	874.5220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45331	Nasopharyngeal medicine administration kit atomizer	An atomizing nozzle intended to be used with the components of a nasopharyngeal medicine administration kit to deliver an accurate dosage of medication into the nasal cavity and pharyngeal areas. This device will attach to a reusable pump for operation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06978579510074	GS1