Catalog Number

1103125

Brand Name

Sensor

Version/Model Number

Airflow Sensor Thermocouple, RoHS Adult Disp

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"

-

For Single-Use

Yes

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

K913396,K913396

Product Code

BZG

Product Code Name

SPIROMETER, DIAGNOSTIC

Public Device Record Key

11add872-3b77-43ca-af2b-c057ebaabac0

Public Version Date

March 01, 2021

Public Version Number

4

DI Record Publish Date

September 18, 2016

Package DI Number

30606959037206

Quantity per Package

10

Contains DI Package

00606959037205

Package Discontinue Date

December 31, 1999

Package Status

Not in Commercial Distribution

Package Type

Multipack