Catalog Number

-

Brand Name

NA

Version/Model Number

Pedi-lite sensor, disposable, Pediatric

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

Product Code

BZK

Product Code Name

Spirometer, monitoring (w/wo alarm)

Public Device Record Key

8758793c-03bd-45a5-9532-92545f9a183b

Public Version Date

August 05, 2022

Public Version Number

9

DI Record Publish Date

August 15, 2016

Package DI Number

20840682103675

Quantity per Package

50

Contains DI Package

00840682103671

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-