Identity
- Trade Name
- Omron 3 Series Upper Arm Blood Pressure Monitor FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- Upper Arm blood pressure monitor with 14-memory storage, irregular heartbeat detection. FDA UDI
- Model / Reference
- BP7100 FDA UDI
- Description
- Upper Arm blood pressure monitor with 14-memory storage, irregular heartbeat detection. FDA UDI
Identifiers
- Catalog Number
- BP7100 FDA UDI
- Primary DI / UDI-DI
- 00073796710026 FDA UDI
- 510(k) Number
- K133379 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
- 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Omron 3 Series Upper Arm Blood Pressure Monitor by Omron Healthcare, 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.
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- 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
- NURSAL — Shenzhen Jamr Medical Technology Co., Ltd. · Class II
Cleared under the same submission
K133379 also covers:
- 3 Series Blood Pressure Monitor — Omron Healthcare, Inc.
- 3 Series Blood Pressure Monitor — Omron Healthcare, Inc.
- 3 Series Upper Arm Blood Pressure Monitor — Omron Healthcare, Inc.
- 5 Series Blood Pressue Monitor — Omron Healthcare, Inc.
- 5 Series Blood Pressue Monitor — Omron Healthcare, Inc.
- Blood Pressure Monitor — Omron Healthcare, Inc.
- Blood Pressure Monitor — Omron Healthcare, Inc.
- Blood Pressure Monitor with Bluetooth — Omron Healthcare, Inc.
- Bronze Upper Arm Blood Pressure Monitor — Omron Healthcare, Inc.
- Countoured Small Arm Cuff 7"-9" — Omron Healthcare, Inc.
- Iron Upper Arm Blood Pressure Monitor — Omron Healthcare, Inc.
- Omron 3 Series Upper Arm Blood Pressure Monitor — Omron Healthcare, 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
- Omron Healthcare, Inc.
Sources (1)
- FDA UDI 0fbffd75-f06c-42bf-8a50-084a03b8223d 37 fields · synced May 30, 2026