Catalog Number

150-691-000

Brand Name

Exchange Select

Version/Model Number

150-691-000

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

fbf034c9-3bb4-4bb2-8ef6-fedfc754d2b4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 12, 2016

Package DI Number

10614299400501

Quantity per Package

12

Contains DI Package

30614299400505

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton