FDA.report

BabySat 3 Rx Sensor

Primary DI
00810099090031
Brand
BabySat 3 Rx Sensor
Company
Owlet Baby Care, Inc.
Model
MSM1NWUCM
Published
2024-01-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DQAOximeter

Product Code Classifications

CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions

SubmissionSupplement
K222597000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K222597000BabySat 3Owlet Babycare, Inc.2023-06-16DQA

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810099090031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810099090031008100990900318100990900310810099090031

GMDN Terms

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

Regulatory Flags

DUNS number
079422657
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810099090024 BabySat 3 Rx Base StationBSM1NWUCM2024-01-08
00810099090079BabySat 3 Rx App2.23.02024-01-08
00810099090086BabySat Monitoring SystemMBM5NNBBK2024-01-08

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