Curelief

GUDID 06956937001457

Portable vibrating mesh nebulizer

Shenzhen Homed Medical Device Co., Ltd.

Nebulizing system, heated Benchtop nebulizer, heated Benchtop nebulizer, heated Benchtop nebulizer, heated Benchtop nebulizer, heated Benchtop nebulizer, heated Benchtop nebulizer, heated

Primary Device ID	06956937001457
NIH Device Record Key	489f630d-86b5-4dfd-8d3d-ecba84594d78
Commercial Distribution Discontinuation	2019-12-19
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Curelief
Version Model Number	JLN-MB005
Company DUNS	421309081
Company Name	Shenzhen Homed Medical Device Co., Ltd.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06956937001457 [Primary]
GS1	16956937001454 [Package] Package: case [20 Units] Discontinued: 2019-12-19 Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K170886

FDA Product Code

CAF	Nebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2020-03-23
Device Publish Date	2019-12-19