Catalog Number

-

Brand Name

agelh

Version/Model Number

BT-308

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K193621,K193621

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

60958ab8-b3da-4505-8768-41592a5b47e2

Public Version Date

February 22, 2021

Public Version Number

2

DI Record Publish Date

December 18, 2020

Package DI Number

16973826010502

Quantity per Package

200

Contains DI Package

06973826010505

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton