Dream Sock Duo Monitoring System, Dusty Rose

Primary DI
00810099091250
Brand
Dream Sock Duo Monitoring System, Dusty Rose
Company
Owlet Baby Care, Inc.
Model
OSS 3.0-M1; OBL 3.0-M1
Device description
The Dream Sock analyzes photoplethysmography data to identify instances when the infant’s pulse rate (PR) and/or oxygen saturation (SpO2) moves outside a preset range, and provides a notification to the caregiver, prompting them to assess the infant. The Dream Sock also displays the infant’s PR and SpO2 values to the caregiver and displays trends in these measured values, and their relationship to the preset ranges, over time. These PR and SpO2 notifications and displays on the Dream Sock are intended for use in infants who are 1 to 18 months of age and between 6 to 30 lbs.
Published
2025-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true

Product Codes#

Code, Name table
CodeName
QYUInfant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QYUInfant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter UseCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810099091250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810099091250008100990912508100990912500810099091250

GMDN Terms#

Term, Definition table
TermDefinition
Multiple vital physiological parameter monitoring system, home-useAn assembly of electrically-powered devices designed to be used by a layperson in the home for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and processing hardware with dedicated software. It typically incorporates a monitoring screen, but may alternatively be connected to an off-the-shelf device for display; it is not intended to be worn on the body.

Regulatory Flags#

DUNS number
079422657
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810099090987Dream Sock Monitoring System - Mint OSS 3.0-M1; OBL 3.0-M12025-10-17
00810099090994Dream Sock Monitoring System - Bedtime BlueOSS 3.0-M1; OBL 3.0-M1 2025-10-17
00810099091007Dream Sock Monitoring System - Dusty Rose OSS 3.0-M1; OBL 3.0-M12025-10-17
00810099091120Dream Sock Monitoring System - Wild ChildOSS 3.0-M1; OBL 3.0-M12025-10-17
00810099091144Dream Sock Monitoring System - Sweet ClementineOSS 3.0-M1; OBL 3.0-M12025-10-17
00810099091229Dream Sock Duo Monitoring System, Blue MistOSS 3.0-M1; OBL 3.0-M12025-10-17
00810099091236Dream Sock Duo Monitoring System, MintOSS 3.0-M1; OBL 3.0-M12025-10-17
00810099091243Dream Sock Duo Monitoring System, Bedtime BlueOSS 3.0-M1; OBL 3.0-M12025-10-17
00810099091267Dream Sock Duo Monitoring System, Sweet ClementineOSS 3.0-M1; OBL 3.0-M12025-10-17
00810099090826Dream Sock App3.02024-02-12
00810099091212Dream Sock Monitoring System - Blue MistOSS 3.0-M1; OBL 3.0-M12025-05-27
00810099090024 BabySat 3 Rx Base StationOBL 3.0-M1 2024-01-08
00810099090031BabySat 3 Rx SensorOSS 3.0-M12024-01-08
00810099090086BabySat Monitoring SystemOSS 3.0-M1; OBL 3.0-M12024-01-08
00810099090079BabySat 3 Rx App2.23.02024-01-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810099090987Dream Sock Monitoring System - Mint Owlet Baby Care, Inc.QYU2025-10-17
00810099090994Dream Sock Monitoring System - Bedtime BlueOwlet Baby Care, Inc.QYU2025-10-17
00810099091007Dream Sock Monitoring System - Dusty Rose Owlet Baby Care, Inc.QYU2025-10-17
00810099091120Dream Sock Monitoring System - Wild ChildOwlet Baby Care, Inc.QYU2025-10-17
00810099091144Dream Sock Monitoring System - Sweet ClementineOwlet Baby Care, Inc.QYU2025-10-17
00810099091229Dream Sock Duo Monitoring System, Blue MistOwlet Baby Care, Inc.QYU2025-10-17
00810099091236Dream Sock Duo Monitoring System, MintOwlet Baby Care, Inc.QYU2025-10-17
00810099091243Dream Sock Duo Monitoring System, Bedtime BlueOwlet Baby Care, Inc.QYU2025-10-17
00810099091267Dream Sock Duo Monitoring System, Sweet ClementineOwlet Baby Care, Inc.QYU2025-10-17
00810099091212Dream Sock Monitoring System - Blue MistOwlet Baby Care, Inc.QYU2025-05-27
00810099090826Dream Sock AppOwlet Baby Care, Inc.QYU2024-02-12
00810099090819Dream Sock AppOwlet Baby Care Inc.QYU2024-02-12