Identity
- Trade Name
- iBloodPressure FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- iBloodPressure Cellular Blood Pressure Monitor, Adult, Large FDA UDI
- Model / Reference
- LS802-GS FDA UDI
- Description
- iBloodPressure Cellular Blood Pressure Monitor, Adult, Large FDA UDI
Identifiers
- Catalog Number
- SM5000-IBAL FDA UDI
- Primary DI / UDI-DI
- 00869876000039 FDA UDI
- 510(k) Number
- K123780 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Circumference — 42 Centimeter FDA UDICircumference — 22 Centimeter FDA UDI
iBloodPressure by Smart Meter Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K123780 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Smart Meter Llc
Sources (1)
- FDA UDI 00409305-d718-4486-aad6-ff66f1a4700c 38 fields · synced Jun 1, 2026