Identity
- Trade Name
- My Medic FDA UDI
- Generic Name
- Aneroid manual sphygmomanometer FDA UDI
- Device Name
- A device designed to measure blood pressure consisting of an inflatable cuff that fits around a limb ( for controlling the air pressure within the cuff, an aneroid manometer, and tubing. The aneroid mano bellows, which expands as the pressure in the cuff increases, and a mechanical amplifier that transm lever to an indicator needle, which rotates around a circular, calibrated scale. The manometer may b on a table, or hand held(portable); blood pressure measurement is taken in conjunction with a stethoscope. FDA UDI
- Model / Reference
- Max0203 FDA UDI
- Description
- A device designed to measure blood pressure consisting of an inflatable cuff that fits around a limb ( for controlling the air pressure within the cuff, an aneroid manometer, and tubing. The aneroid mano bellows, which expands as the pressure in the cuff increases, and a mechanical amplifier that transm lever to an indicator needle, which rotates around a circular, calibrated scale. The manometer may b on a table, or hand held(portable); blood pressure measurement is taken in conjunction with a stethoscope. FDA UDI
Identifiers
- Catalog Number
- Blue FDA UDI
- Primary DI / UDI-DI
- 00850029189787 FDA UDI
- 510(k) Number
- K190902 FDA UDI
- FDA Product Code
- DXQ FDA UDILDE FDA UDI
- GMDN Term
- Aneroid manual sphygmomanometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1120 FDA UDI870.1875 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
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
My Medic by My Medic — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K190902 also covers:
- HOMEDICS — FKA DISTRIBUTING CO., LLC
- 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 |
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Manufacturer
- Manufacturer
- My Medic
Sources (1)
- FDA UDI 4e3be512-c867-49f5-82d1-d00dab379bf5 36 fields · synced May 30, 2026