Catalog Number

-

Brand Name

Curelief

Version/Model Number

JLN-MB005

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 19, 2019

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K170886,K170886

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

489f630d-86b5-4dfd-8d3d-ecba84594d78

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

December 19, 2019

Package DI Number

16956937001454

Quantity per Package

20

Contains DI Package

06956937001457

Package Discontinue Date

December 19, 2019

Package Status

Not in Commercial Distribution

Package Type

case