Catalog Number

-

Brand Name

NA

Version/Model Number

D-LITE PATIENT SPIROMETRY SET 2104297-00

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K183394,K211171,K183394,K211171

Product Code

BZK

Product Code Name

Spirometer, monitoring (w/wo alarm)

Public Device Record Key

0899c513-25ad-4431-a393-f6e6f721c5e9

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

June 19, 2019

Package DI Number

00840682138154

Quantity per Package

20

Contains DI Package

00840682138147

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-