Identity
- Trade Name
- HealthSmart FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- TWO PARTY HOME BP UNIT BLACK ADULT FDA UDI
- Model / Reference
- 04-176-021 FDA UDI
- Description
- TWO PARTY HOME BP UNIT BLACK ADULT FDA UDI
Identifiers
- Catalog Number
- 04-176-021 FDA UDI
- Primary DI / UDI-DI
- 00767056041769 FDA UDI
- 510(k) Number
- K082542 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- GMDN Term
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1120 FDA UDI
- Commercial Distribution
- 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
HealthSmart by Dms Holdings, Inc., — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Automatic-inflation electronic sphygmomanometer, portable, arm/wrist.
- Arm Type Automatic Blood Pressure Monitor — Shenzhen Jiacom Technology Co., Ltd · Class II
- Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System — DARIOHEALTH CORP. · Class II
- MoDash — Shenzhen Urion Technology Co., Ltd. · Class II
- Veridian Healthcare — VERIDIAN HEALTHCARE · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- BRIGHT LIFE — Shenzhen Urion Technology Co., Ltd. · Class II
- RemoteCare 4U — Guangdong Transtek Medical Electronics Co., Ltd · Class II
- Omron 3 Series Upper Arm Blood Pressure Monitor — Omron Healthcare, Inc. · Class II
Cleared under the same submission
K082542 also covers:
- ASA Techmed — CARDICARE COMPANY LTD
- Leader — Cardinal Health 110, Inc.
- MABIS — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
- MABIS — DMS HOLDINGS, INC.,
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
- Dms Holdings, Inc.,
Sources (1)
- FDA UDI 146f2230-adab-4bc5-b2ee-ee7765c26575 35 fields · synced May 31, 2026