Identity
- Trade Name
- BabySat Monitoring System FDA UDI
- Generic Name
- Multiple vital physiological parameter monitoring system, home-use FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- OSS 3.0-M1; OBL 3.0-M1 FDA UDI
- 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 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810099090086 FDA UDI
- 510(k) Number
- K222597 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Multiple vital physiological parameter monitoring system, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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
Yes
FDA UDI
Category: Multiple vital physiological parameter monitoring system, home-use
BabySat Monitoring System by Owlet Baby Care, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Owlet Baby Care, Inc.
Sources (1)
- FDA UDI 6076540c-6b6c-4731-9cfe-7b2c53db35fe 34 fields · synced May 30, 2026