Identity
- Trade Name
- Physiologic essentiA Blood Pressure Monitor FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- Large easy to read screen • Multi-user (4 x 30 memories) • Heart rate indicator • Date and time indicator • Large cuff size is available (#106-931) Meets all required Canadian & US FDA Standards including ANSI/AAMI SP-10 & ESH International Protocol Includes: Blood pressure monitor and medium size arm cuff, fits 8.7” to 14.2” (22 to 36 cm) arm circumference Requires 4 AA batteries (not included) FDA UDI
- Model / Reference
- 106-930 FDA UDI
- Description
- Large easy to read screen • Multi-user (4 x 30 memories) • Heart rate indicator • Date and time indicator • Large cuff size is available (#106-931) Meets all required Canadian & US FDA Standards including ANSI/AAMI SP-10 & ESH International Protocol Includes: Blood pressure monitor and medium size arm cuff, fits 8.7” to 14.2” (22 to 36 cm) arm circumference Requires 4 AA batteries (not included) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00057565069362 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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Physiologic essentiA Blood Pressure Monitor by A.M.G. Médicale Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- A.M.G. Médicale Inc
Sources (1)
- FDA UDI 705baf2b-aeb5-4b6c-bc7e-12ffb3b0be4a 33 fields · synced Jun 8, 2026