FDA UDI
In Commercial Distribution
🇺🇸 United States
BabySat Monitoring System
DI: 00810099090086
·
Model: MBM5NNBBK
·
Owlet Baby Care Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- BabySat Monitoring System
- Primary DI
- 00810099090086
- Version / Model
- MBM5NNBBK
- Company Name
- Owlet Baby Care Inc.
- Labeler DUNS
- 079422657
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-08
- Public Version
- 1
- Public Version Date
- 2024-01-16
- Public Version Status
- New
- Public Device Record Key
- 6076540c-6b6c-4731-9cfe-7b2c53db35fe
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
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65669 | Multiple vital physiological parameter monitoring system, home-use | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810099090086 | GS1 | ||||
| Package | 00810099090192 | GS1 | 3 | In Commercial Distribution | ||
| Package | 10810099090199 | GS1 | 12 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222597 | 000 |