FDA UDI
In Commercial Distribution
🇺🇸 United States
Microlife
DI: 06970388169450
·
Model: Cuff-L-WBPO
·
MICROLIFE USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Microlife
- Primary DI
- 06970388169450
- Version / Model
- Cuff-L-WBPO
- Company Name
- MICROLIFE USA, INC.
- Labeler DUNS
- 176387785
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-01
- Public Version
- 1
- Public Version Date
- 2024-08-09
- Public Version Status
- New
- Public Device Record Key
- 599bc26e-8cf8-4b82-8b30-1a06c8a8bc18
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 870.1130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64511 | Arrythmia-detection sphygmomanometer | An electrically-powered device designed to noninvasively measure blood pressure and, in addition, detect cardiac arrythmias [e.g., atrial fibrillation (AF)] by automatically inflating and deflating a cuff that typically fits around a limb (arm or thigh); it may also measure the heart rate and mean arterial pressure. It typically incorporates a display and controls, and may include a blood pressure cuff with connection tubing. The measurements may be analysed at a medical facility, typically using a computer or mobile phone with a dedicated software. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16970388169457 | GS1 | Carton packing | 40 | In Commercial Distribution | |
| Primary | 06970388169450 | GS1 |