Identity
- Trade Name
- Welch Allyn, Inc. FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- Welch Allyn Home Blood Pressure Monitor (1500 Series) with D-Ring Standard Wide Cuff (22-42cm), 4 Alkaline AA batteries. Home Blood Pressure Monitor may be used standalone, or in conjunction with the Welch Allyn Home Hypertension Program Clinical Portal and Patient Application. May also be integrated into third party Remote Patient Monitoring (RPM) solutions. FDA UDI
- Model / Reference
- 901042 FDA UDI
- Description
- Welch Allyn Home Blood Pressure Monitor (1500 Series) with D-Ring Standard Wide Cuff (22-42cm), 4 Alkaline AA batteries. Home Blood Pressure Monitor may be used standalone, or in conjunction with the Welch Allyn Home Hypertension Program Clinical Portal and Patient Application. May also be integrated into third party Remote Patient Monitoring (RPM) solutions. FDA UDI
Identifiers
- Catalog Number
- RPM-BP100 FDA UDI
- Primary DI / UDI-DI
- 00732094246131 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
No
FDA UDI
Welch Allyn, Inc. by Welch Allyn, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Welch Allyn, Inc.
Sources (1)
- FDA UDI b9892e3a-d425-4cfd-b6ca-b917ca928674 36 fields · synced Jun 1, 2026