Catalog Number

-

Brand Name

Elcare

Version/Model Number

JXB-311

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"

Yes

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

b2787503-8532-45eb-9ade-ac7910ab206c

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

October 20, 2020

Package DI Number

36947656113164

Quantity per Package

80

Contains DI Package

06947656113163

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cartoon