Catalog Number

3104330S

Brand Name

Mini Wright

Version/Model Number

3104330S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K952713,K952713,K952713

Product Code

BZH

Product Code Name

Meter, Peak Flow, Spirometry

Public Device Record Key

0e4f8db0-f502-4ccc-a95c-b94e5ac08d09

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 07, 2016

Package DI Number

05023323001481

Quantity per Package

12

Contains DI Package

05023323001474

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-