Dream Sock (Mint)

Primary DI

00810099090802

Basic UDI-DI Code

081009909DreamSockHNNB

Reference

BMRHNNMIM; PSRHNNMIM

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2b

Status

On The Market

Manufacturer

Owlet Baby Care, Inc.

Dream SockTM is intended for routine, in-home surveillance of healthy infants by measuring oxygen saturation (SpO2) and pulse rate (PR). Dream Sock software analyzes photoplethysmography data to identify instances when the infant’s PR and/or SpO2 moves outside a preset range, and provides a notification to the caregiver, prompting them to assess the infant. The notifications and associated data are intended to supplement the decision by caregivers to seek additional guidance for medical care of the infant. The feature is not intended to replace traditional methods of diagnosis and/or treatment.

The Basic UDI-DI associated with this device has 3 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDR).