Catalog Number

3313

Brand Name

Metaphor Flow Sensor

Version/Model Number

Infant

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K093080,K093080

Product Code

BZC

Product Code Name

Calculator, Pulmonary Function Data

Public Device Record Key

f9da1215-b47d-4532-84fc-ae16527884c5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-