Curelief

Basic Information

• Brand Name: Curelief
• Primary DI: 06956937001457
• Version / Model: JLN-MB005
• Company Name: Shenzhen Homed Medical Device Co., Ltd.
• Labeler DUNS: 421309081
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-19
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 489f630d-86b5-4dfd-8d3d-ecba84594d78
• Distribution End Date: 2019-12-19

Device Description

Portable vibrating mesh nebulizer

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	868.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12716	Benchtop nebulizer, heated	An assembly of devices intended to be used in the home and clinical settings to generate warmed aerosolized medication/fluids (e.g., pharmacological drugs, medical cannabis) for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)] or various other conditions (e.g., chronic pain). It typically consists of a benchtop assembly with an electrically-powered generator, a reservoir, a heating element, dosing capsules, and a hand-held nebulizing/inhalation compartment (e.g., inflatable balloon with mouthpiece).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06956937001457	GS1
Package	16956937001454	GS1	case	20	Not in Commercial Distribution	2019-12-19

Premarket Submissions

Submission Number	Supplement Number
K170886	000