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Dream Sock App

FDA UDI

Class II (US FDA UDI)

by Owlet Baby Care, Inc.

Identity

Trade Name
Dream Sock App FDA UDI
Generic Name
Multiple vital physiological parameter monitoring system, home-use FDA UDI
Device Name
Dream Sock Software App. The Dream Sock is intended for over-the-counter (OTC) use only in a home environment. It is not intended to provide notification for every episode of the unexpected occurrences of elevated or depressed PR or a low SpO2 level; rather, the Dream Sock is intended to provide a notification only when sufficient data are available for analysis. The notifications and associated data can be used to supplement the decision by caregivers to seek additional guidance for medical care of the infant. The Dream Sock is not intended to replace traditional methods of monitoring, diagnosis or treatment. FDA UDI
Model / Reference
3.0 FDA UDI
Description
Dream Sock Software App. The Dream Sock is intended for over-the-counter (OTC) use only in a home environment. It is not intended to provide notification for every episode of the unexpected occurrences of elevated or depressed PR or a low SpO2 level; rather, the Dream Sock is intended to provide a notification only when sufficient data are available for analysis. The notifications and associated data can be used to supplement the decision by caregivers to seek additional guidance for medical care of the infant. The Dream Sock is not intended to replace traditional methods of monitoring, diagnosis or treatment. FDA UDI

Identifiers

Primary DI / UDI-DI
00810099090819 FDA UDI
510(k) Number
DEN220091 FDA UDI
FDA Product Code
QYU FDA UDI
GMDN Term
Multiple vital physiological parameter monitoring system, home-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2705 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple vital physiological parameter monitoring system, home-use

Dream Sock App by Owlet Baby Care, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple vital physiological parameter monitoring system, home-use.

Manufacturer's product page: Dream Sock

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Owlet Baby Care, Inc.

Sources (1)

  • FDA UDI c1f967ea-e056-49b2-a909-2e95ed1e8da9 34 fields · synced May 30, 2026