Catalog Number

-

Brand Name

Dreambaby

Version/Model Number

L320

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

K103407

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

54d31138-5fb6-4ef8-a1a2-f33148ef9c2a

Public Version Date

October 21, 2019

Public Version Number

1

DI Record Publish Date

October 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-