FDA UDI
In Commercial Distribution
🇺🇸 United States
Hypertension Notification Feature (HTNF)
DI: 00195949001789
·
Model: Feature version 1.X
·
APPLE INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Hypertension Notification Feature (HTNF)
- Primary DI
- 00195949001789
- Version / Model
- Feature version 1.X
- Company Name
- APPLE INC.
- Labeler DUNS
- 060704780
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-18
- Public Version
- 1
- Public Version Date
- 2025-09-26
- Public Version Status
- New
- Public Device Record Key
- 9d1c233b-bc33-48ff-b0fd-eb1b5761da70
Device Description
Hypertension Notification Feature watchOS (HTNF)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| SFR | Hypertension Machine Learning-Based Notification Software | Cardiovascular | 870.2380 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58884 | Self-care monitoring/reporting software | An application software program designed for the continual collection and aggregation of a patient's self-care data to promote communication between patient and healthcare provider, to facilitate a patient's self-care by using rules defined during use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional, and/or exercise information in the home, which may include medication administration information captured from enabled injection devices and data from wearable devices, providing care plan, journal, medication advice, and/or messaging functionalities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00195949001789 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250507 | 000 |