Question 1

What types of medical devices does A.M.G. Médicale Inc manufacture?

Accepted Answer

A.M.G. Médicale Inc produces a range of medical devices primarily focused on patient monitoring and clinical care. These include disposable and reusable items such as electronic thermometers (oral, rectal, and infrared), portable and non-portable blood pressure monitors, nitrile examination gloves, multifunction body cushions, manual commodes, and inflatable invalid rings. The devices are designed for both home and clinical use to support patient comfort, mobility, and vital sign measurement.

Question 2

Where is A.M.G. Médicale Inc based, and what does that mean for its regulatory oversight?

Accepted Answer

A.M.G. Médicale Inc is headquartered in the United States, which means its devices are subject to FDA regulations. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. regulatory requirements. Being based in the U.S. also aligns its devices with FDA classification standards, including Class I and Class II categorizations.

Question 3

Which regulatory registries or databases list A.M.G. Médicale Inc’s devices?

Accepted Answer

A.M.G. Médicale Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system provides a standardized identification for medical devices, improving tracking, safety monitoring, and regulatory compliance. This listing ensures transparency and accessibility for healthcare providers, regulators, and patients regarding the company’s products.

Question 4

How are A.M.G. Médicale Inc’s devices classified under FDA regulations?

Accepted Answer

A.M.G. Médicale Inc’s devices fall into two primary FDA classification categories: Class I and Class II. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body system it interacts with, as outlined in FDA regulations.

Question 5

What kinds of devices does A.M.G. Médicale Inc specialize in for patient monitoring and support?

Accepted Answer

A.M.G. Médicale Inc specializes in devices that address both vital sign monitoring and patient support. For monitoring, it offers electronic thermometers (like oral, rectal, and infrared models) and blood pressure monitors (portable and non-portable). For patient support, the company provides items such as nitrile gloves for hygiene, multifunction body cushions for comfort, manual commodes for mobility assistance, and inflatable invalid rings to aid in patient positioning or transfers. These devices cater to clinical and home care settings.

Device	Model / Reference	Registries	Class	Status
Physiologic essentiA Blood Pressure Monitor	106-930	FDA UDI	Class II	Active
MedPro Inflatable Rubber Invalid Ring	745-176	FDA UDI	Class I	Active
Accuflex5 VU Thermometer, from Physio Logic	016-651	FDA UDI	Class II	Active
OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves by MedPro	012-107	FDA UDI	Class I	Active
OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves	012-097	FDA UDI	Class I	Active
Physiologic Accuflex 10 Flexible Digital Thermometer	016-635 Version 1	FDA UDI	Class II	Active
OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves by MedPro	012-127	FDA UDI	Class I	Active
AMG Medical Foam Invalid Ring	745-173	FDA UDI	Class I	Active
Accuflexpro+ Rectal Thermometer (red)	016-649	FDA UDI	Class II	Active
Avantia Portable Steel Commode	771-315	FDA UDI	Class I	Active
Avantia BPM-70 Automatic Blood Pressure Monitor	107-930	FDA UDI	Class II	Active
Physiologic LuminA Blood Pressure Monitor	106-934	FDA UDI	Class II	Active
Accuflexpro+ Oral Thermometer (blue)	016-648	FDA UDI	Class II	Active
Avantia Ultra-Comfort Commode	771-317	FDA UDI	Class I	Active
PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, RECTAL (Red)	016-619	FDA UDI	Class II	Active
Physio Logic Digital 10 Thermometer	016-644	FDA UDI	Class II	Active
PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, Oral (Blue)	016-618	FDA UDI	Class II	Active
AMG Medical Foam Invalid Ring	745-166	FDA UDI	Class I	Unknown
Physio Logic Accuflex Digital Thermometer	016-628	FDA UDI	Class II	Active
PhysioLogic DigiPro+ 30 second Digital Oral Thermometer	016-625	FDA UDI	Class II	Active
OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves by MedPro	012-137	FDA UDI	Class I	Active
ProScan Non-Contact Infrared Thermometer by Physio Logic	016-660	FDA UDI	Class II	Active
MedPro Inflatable Rubber Invalid Ring	745-174	FDA UDI	Class I	Active
Physiologic Insta-Therm Quick-Scan Thermometer	016-670	FDA UDI	Class II	Active
Avantia - M-Safe Adjustable Home Bed Rail	776-650	FDA UDI	Class I	Active
FeverScan Fever Indicators by Physio Logic	016-800	FDA UDI	Class II	Active
ProActive Alevia 2 in 1 TENS	715-425	FDA UDI	Class II	Active
Physiologic Fever-Bugz Stick-On Fever Indicators	016-720US	FDA UDI	Class II	Active
OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves	012-117	FDA UDI	Class I	Active
Physio Logic Digiflex 10 Thermometer	016-645	FDA UDI	Class II	Active
Physio Logic Accuflex Digital Thermometer - Red	016-629	FDA UDI	Class II	Active
Avantia BPM-80 Blood Pressure	107-934	FDA UDI	Class II	Active
Physiologic Accuflex Pro+ Digital Thermometer	016-658	FDA UDI	Class II	Active
Physiologic Accuflex 5 Flexible Digital Thermometer	016-637 Version 1	FDA UDI	Class II	Active

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