Identity
- Trade Name
- Omron Blood Pressure Monitor FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- Blood Pressure Monitor w/Bluetooth, Comparison Display, pre-formed Comfit Cuff, irregular heartbeat detector and 200 memory storage. FDA UDI
- Model / Reference
- BP7455CAN-CD6 FDA UDI
- Description
- Blood Pressure Monitor w/Bluetooth, Comparison Display, pre-formed Comfit Cuff, irregular heartbeat detector and 200 memory storage. FDA UDI
Identifiers
- Catalog Number
- BP7455CAN-CD6 FDA UDI
- Primary DI / UDI-DI
- 00073796745530 FDA UDI
- 510(k) Number
- K133383 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
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
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 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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- 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
K133383 also covers:
- 10 Series Plus Bluetooth Smart Blood Pressure Monitor — Omron Healthcare, Inc.
- 10 Series Plus Bluetooth Smart Blood Pressure Monitor — Omron Healthcare, Inc.
- 7 Series Plus Bluetooth Smart Blood Pressure Monitor — Omron Healthcare, Inc.
- 7 Series Plus Bluetooth Smart Blood Pressure Monitor — Omron Healthcare, Inc.
- Easy Wrap Comfit Cuff 9"-17" — Omron Healthcare, Inc.
- Omron 10 Series Connected Upper Arm Blood Pressure Monitor — Omron Healthcare, Inc.
- Omron 10 Series Upper Arm Blood Pressure Monitor — Omron Healthcare, Inc.
- Omron 7 Series Connected Upper Arm Blood Pressure Monitor — Omron Healthcare, Inc.
- Omron 7 Series Upper Arm Blood Pressure Monitor — Omron Healthcare, Inc.
- Omron 7 Series Upper Arm Blood Pressure Monitor — Omron Healthcare, Inc.
- Omron Blood Pressure Monitor — Omron Healthcare, Inc.
- Omron Easy Wrap Comfit Cuff — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Omron Healthcare, Inc.
Sources (1)
- FDA UDI 031e4552-40fa-4dfd-8269-5ff1ea3e53ef 37 fields · synced May 30, 2026