FDA UDI
In Commercial Distribution
🇺🇸 United States
Pro Health Mini: Talking Blood Pressure Monitor
DI: 00850632007263
·
Model: 7263
·
HOME AIDE DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Pro Health Mini: Talking Blood Pressure Monitor
- Primary DI
- 00850632007263
- Version / Model
- 7263
- Company Name
- HOME AIDE DIAGNOSTICS, INC.
- Labeler DUNS
- 783518983
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-08
- Public Version
- 1
- Public Version Date
- 2024-10-16
- Public Version Status
- New
- Public Device Record Key
- 752bfe6f-9c1b-4ce7-ab5d-1f7751703727
Device Description
Arm-type fully automatic digital blood pressure monitor. LCD digital display. Oscillometric measurement method. 0mmHg~300mmHg pressure range. 30-180 Beats/Minute. 3mmHg pressure accuracy. 5% pulse accuracy. Automatic Pressurization. 120 Memories in Four groups with date and time. low battery detection. Automatic Power-off. 4 AA batteries. Approximately 2 months at 3 test per day battery life. 22.0cm ~36.0cm (8.6" ~14.2") cuff cirfumference.
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
- 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 |
|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 870.1130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45617 | Automatic-inflation electronic sphygmomanometer, portable, arm/wrist | An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850632007260 | GS1 | Case | 30 | In Commercial Distribution | |
| Primary | 00850632007263 | GS1 |
Customer Contacts
- Phone
- 1-800-915-0116
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191894 | 000 |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 14 – 131 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 55 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 41 – 104 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius