Catalog Number

-

Brand Name

Alcedo

Version/Model Number

AE171

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

K172795,K172795

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

0269e6de-2008-4609-935b-ab0e9b1cb077

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

October 22, 2019

Package DI Number

10856471007171

Quantity per Package

100

Contains DI Package

00856471007174

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master carton