R.G. ENTERPRISES (U.S.A.), INC.

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Device Description : Thermal regulating systems to prevent/treat hypothermia in pre clinical settings Thermal regulating systems to prevent/treat hypothermia in pre clinical settings or treatment on site. Intended for use at rescue scene, during patient transport by air or ground to medical facility. Selectable temperature ranging from 98.6F to 104F via control unit with visual and acoustic alarm systems to indicate when temperature is reached. Operates using battery or medical grade power supply.

Device Class : 2

Duns Number: 928998905

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Device Description : Thermal regulating systems to prevent/treat hypothermia in pre clinical settings Thermal regulating systems to prevent/treat hypothermia in pre clinical settings or treatment on site. Intended for use at rescue scene, during patient transport by air or ground to medical facility. Selectable temperature ranging from 98.6F to 104F via control unit with visual and acoustic alarm systems to indicate when temperature is reached. Operates using battery or medical grade power supply.

Device Class : 2

Duns Number: 928998905

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Device Description : Probe Covers (TIDI) are a latex free barrier used for Geratherm mercury free ora Probe Covers (TIDI) are a latex free barrier used for Geratherm mercury free oral or rectal thermometers. They are a single use disposable item.

Device Class :

Duns Number: 928998905

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 1

- Catalog Number : 501501

Device Description : Lightweight portable continuous temperature monitor used to measure human body t Lightweight portable continuous temperature monitor used to measure human body temperature and stores temperature readings at preset time intervals. Features on/off, mode access and scrolling feature buttons, special Lock feature for safety, belt clip on back of monitor, features both High and Low adjustable alarm settings, uses 2, 1.5 volt AA batteries, disposable 1M or 2M temperature probes, dimensions (3.16 x 2.37 x .71).

Device Class : 2

Duns Number: 928998905

Premarket Exempt : No

Product Code : FLL

Prescription Use : Yes

Device Count : 1

Device Description : The Geratherm mercury free oral glass thermometers are designed with an inner an The Geratherm mercury free oral glass thermometers are designed with an inner and outer barrel of glass. The inner barrel contains Galinstan a non-toxic liquid metal comprised of Gallium, Indium and Tin. It measures body temperature in both Celsius and Fahrenheit, and functions like the standard mercury thermometer. When heat is applied, such as placing the tip of the thermometer under the tongue the Galinstan rises up the column until the maximum temperature is achieved...normally in 3 minutes. The temperature measuring range is from 95° F (35.5°C) to 108°F (42°C). A protective plastic case with a green cap is provided.

Device Class : 2

Duns Number: 928998905

Premarket Exempt : Yes

Product Code : FLK

Prescription Use : No

Device Count : 1

Device Description : The Geratherm mercury free oral glass thermometers are designed with an inner an The Geratherm mercury free oral glass thermometers are designed with an inner and outer barrel of glass. The inner barrel contains Galinstan a non-toxic liquid metal comprised of Gallium, Indium and Tin. It measures body temperature in both Celsius and Fahrenheit, and functions like the standard mercury thermometer. When heat is applied, such as placing the tip of the thermometer under the tongue the Galinstan rises up the column until the maximum temperature is achieved...normally in 3 minutes. The temperature measuring range is from 95° F (35.5°C) to 108°F (42°C). A protective plastic case with a green cap is provided.

Device Class : 2

Duns Number: 928998905

Premarket Exempt : Yes

Product Code : FLK

Prescription Use : No

Device Count : 1

Device Description : MagnaTherm mercury free oral glass thermometers is designed with an inner and ou MagnaTherm mercury free oral glass thermometers is designed with an inner and outer barrel of glass. The inner barrel contains Galinstan a non-toxic liquid metal comprised of Gallium, Indium and Tin. It measures body temperature in both Celsius and Fahrenheit, and functions like the standard mercury thermometer. When heat is applied, such as placing the tip of the thermometer under the tongue the Galinstan rises up the column until the maximum temperature is achieved...normally in 3 minutes. The temperature measuring range is from 95° F (35.5°C) to 108°F (42°C). This thermometer is encased in an optical grade magnifying case with a white retainage allowing the thermometer to slide easily in and out of the case as well as enhancement of the thermometer reading.

Device Class : 2

Duns Number: 928998905

Premarket Exempt : Yes

Product Code : FLK

Prescription Use : No

Device Count : 1

Device Description : MagnaTherm Clinical mercury free oral glass thermometers is designed with an inn MagnaTherm Clinical mercury free oral glass thermometers is designed with an inner and outer barrel of glass. The inner barrel contains Galinstan a non-toxic liquid metal comprised of Gallium, Indium and Tin. It measures body temperature in both Celsius and Fahrenheit, and functions like the standard mercury thermometer. When heat is applied, such as placing the tip of the thermometer under the tongue the Galinstan rises up the column until the maximum temperature is achieved...normally in 3 minutes. The temperature measuring range is from 95° F (35.5°C) to 108°F (42°C). This thermometer is encased in an optical grade magnifying case with a white retainer allowing the thermometer to slide easily in and out of the case as well as enhancement of the thermometer reading.

Device Class : 2

Duns Number: 928998905

Premarket Exempt : Yes

Product Code : FLK

Prescription Use : No

Device Count : 1

Device Description : The Geratherm mercury free rectal glass thermometers are designed with an inner The Geratherm mercury free rectal glass thermometers are designed with an inner and outer barrel of glass. The inner barrel contains Galinstan a non-toxic liquid metal comprised of Gallium, Indium and Tin. It measures body temperature in both Celsius and Fahrenheit, and functions like the standard mercury thermometer. When heat is applied, such as placing the tip of the thermometer in the rectum the Galinstan rises up the column until the maximum temperature is achieved...normally in 3 minutes. The temperature measuring range is from 95° F (35.5°C) to 108°F (42°C). The fluted tip of the thermometer prevents over insertion. A protective plastic case with a red top is provided.

Device Class : 2

Duns Number: 928998905

Premarket Exempt : Yes

Product Code : FLK

Prescription Use : No

Device Count : 1

Device Description : The Geratherm mercury free rectal glass thermometers are designed with an inner The Geratherm mercury free rectal glass thermometers are designed with an inner and outer barrel of glass. The inner barrel contains Galinstan a non-toxic liquid metal comprised of Gallium, Indium and Tin. It measures body temperature in both Celsius and Fahrenheit, and functions like the standard mercury thermometer. When heat is applied, such as placing the tip of the thermometer in the rectum the Galinstan rises up the column until the maximum temperature is achieved...normally in 3 minutes. The temperature measuring range is from 95° F (35.5°C) to 108°F (42°C). The fluted tip of the thermometer prevents over insertion. A protective plastic case with a red top is provided.

Device Class : 2

Duns Number: 928998905

Premarket Exempt : Yes

Product Code : FLK

Prescription Use : No

Device Count : 1