Identity
- Trade Name
- HOMEDICS FDA UDI
- Generic Name
- Aneroid manual sphygmomanometer FDA UDI
- Device Name
- manual arm blood pressure monitor FDA UDI
- Model / Reference
- BPM-700 FDA UDI
- Description
- manual arm blood pressure monitor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00031262105936 FDA UDI
- 510(k) Number
- K190902 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- GMDN Term
- Aneroid manual sphygmomanometer 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
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: Aneroid manual sphygmomanometer
Homedics by Fka Distributing Co., Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Aneroid manual sphygmomanometer.
- Diagnostix™ — American Diagnostic Corporation · Class II
- Diagnostix™ — American Diagnostic Corporation · Class II
- e-mega® black, disinfectable one-piece cuff, small adult size 2-tube — Rudolf Riester GmbH & Co. KG · Class II
- Diagnostix™ — American Diagnostic Corporation · Class II
- Princess — American Diagnostic Corporation · Class II
- Diagnostix™ — American Diagnostic Corporation · Class II
- E-sphyg™ — American Diagnostic Corporation · Class II
- BAUM — W.A. BAUM CO., INC. · Class II
Cleared under the same submission
K190902 also covers:
- My Medic — My Medic
- PARAMED — SILEX GLOBAL LLC
- PARAMED — SILEX GLOBAL LLC
- PARAMED — SILEX GLOBAL LLC
- PARAMED — SILEX GLOBAL LLC
- PARAMED — SILEX GLOBAL LLC
- PARAMED — SILEX GLOBAL LLC
- Blood Pressure Meter — Wenzhou Renhua Instruments Co., Ltd.
- Blood Pressure Meter — Wenzhou Renhua Instruments Co., Ltd.
- Blood Pressure Meter — Wenzhou Renhua Instruments Co., Ltd.
- Blood Pressure Meter — Wenzhou Renhua Instruments Co., Ltd.
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
- Fka Distributing Co., Llc
Sources (1)
- FDA UDI a2876715-6191-4f62-8ab1-fbfded8f07fe 34 fields · synced Jun 8, 2026