Catalog Number

-

Brand Name

Premom Smart Basal Thermometer

Version/Model Number

EBT-380

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

K160308,K160308

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

9b921807-94a9-4059-ad53-eadfac88cd90

Public Version Date

September 08, 2022

Public Version Number

1

DI Record Publish Date

August 31, 2022

Package DI Number

10810038633777

Quantity per Package

80

Contains DI Package

00810038633770

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-