FDA UDI
In Commercial Distribution
🇺🇸 United States
Electronlc Blood Pressure Monltor
DI: 06971344890616
·
Model: KWL-W01
·
Dongguan Kangweile Electronic Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Electronlc Blood Pressure Monltor
- Primary DI
- 06971344890616
- Version / Model
- KWL-W01
- Company Name
- Dongguan Kangweile Electronic Technology Co., Ltd.
- Labeler DUNS
- 402740499
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-17
- Public Version
- 4
- Public Version Date
- 2025-12-29
- Public Version Status
- Update
- Public Device Record Key
- e2513360-3d54-45a1-b444-0d58b1368b24
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 18107 | Noninvasive blood pressure physical simulator | An instrument designed to mimic the pressure variations acting on the cuff of noninvasive arterial blood pressure monitoring/measuring devices when placed on a patient's arm. It typically simulates blood pressure values (e.g., systolic, diastolic, mean) and abnormal states (e.g, hypertensive, hypotensive). It usually consists of an internal pump to generate the testing pressures, manometers, electronic circuitry, and a display. The device is used to test oscillometric noninvasive blood pressure monitors and electronic sphygmomanometers as a complete set including the transducer; some may also be used to test auscultatory sphygmomanometers. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06971344890616 | GS1 |