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Extra Large D-ring Cuff, Telehealth, Blood Pressure Monitor
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Extra Large D-ring Cuff, Telehealth, Blood Pressure Monitor FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Model / Reference
- HEM-RXL31 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00073796842314 FDA UDI
- 510(k) Number
- K163235 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Blood pressure cuff, reusable 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood pressure cuff, reusable
Extra Large D-ring Cuff, Telehealth, Blood Pressure Monitor by Omron Healthcare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood pressure cuff, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Orbit-K — SUNTECH MEDICAL, INC. · Class II
- Disposable Cuff — SUNTECH MEDICAL, INC. · Class II
- MDF® — MDF Instruments Medifriend Inc. · Class II
- Disposable Cuff — SUNTECH MEDICAL, INC. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Sklar® — Sklar Corporation · Class II
Cleared under the same submission
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 0440a2f8-0742-464e-9aa5-be6cfa017b85 35 fields · synced May 30, 2026