FDA UDI
In Commercial Distribution
🇺🇸 United States
Hello Heart
DI: 04719872489238
·
Model: HHBPA-CUFFXL
·
HEALTH & LIFE CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Hello Heart
- Primary DI
- 04719872489238
- Version / Model
- HHBPA-CUFFXL
- Company Name
- HEALTH & LIFE CO., LTD.
- Labeler DUNS
- 657836743
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-04
- Public Version
- 1
- Public Version Date
- 2025-12-12
- Public Version Status
- New
- Public Device Record Key
- 4f77b1db-87a0-4828-b00d-26e74ab7d7e3
Device Description
XL size cuff with connector for BPM device
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 870.1130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16173 | Automatic-inflation electronic sphygmomanometer, non-portable | An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-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 not designed to be portable and is typically used bedside. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04719872489238 | GS1 | ||||
| Package | 14719872489235 | GS1 | 50 | In Commercial Distribution |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 700 – 1060 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius