FDA.reportPublic FDA data

BabySat Monitoring System

Primary DI
00810099090086
Brand
BabySat Monitoring System
Company
Owlet Baby Care, Inc.
Model
OSS 3.0-M1; OBL 3.0-M1
Device description
BabySat unit composed of one base station, one sensor, two socks and the App. The BabySat 3 pulse oximeter is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse rate. It is indicated for spot-checking and/or continuous monitoring of well-perfused patients greater than one month old up to 18 months old and weighing between 6 and 30 lbs., in the home environment
Published
2024-01-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222597000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222597000BabySat 3Owlet Babycare, Inc.2023-06-16DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810099090192PackageGS13In Commercial Distribution
10810099090199PackageGS112In Commercial Distribution
00810099090086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810099090192008100990901928100990901920810099090192
1081009909019910810099090199
00810099090086008100990900868100990900860810099090086

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.

Sterilization Methods#

Method table
Method

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
00810099091250Dream Sock Duo Monitoring System, Dusty RoseOSS 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
00810099090079BabySat 3 Rx App2.23.02024-01-08

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