| Primary Device ID | 00614801200301 |
| NIH Device Record Key | aa5d6770-005d-4cb2-a025-5b59836d0fb7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GERATHERM MERCURY FREE GLASS ORAL THERMOMETER |
| Version Model Number | RETAIL GLASS ORAL THERMOMETER |
| Catalog Number | 20030 |
| Company DUNS | 928998905 |
| Company Name | R.G. ENTERPRISES (U.S.A.), INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 248-504-6726 |
| MaryRN@rgmd.com | |
| Phone | 248-504-6726 |
| MaryRN@rgmd.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00614801200301 [Primary] |
| FLK | Thermometer, Clinical Mercury |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-02-21 |
| Device Publish Date | 2016-09-01 |
| 16148015015013 - DataTherm II | 2020-05-07 Lightweight portable continuous temperature monitor used to measure human body temperature and stores temperature readings at pr |
| 20614801200107 - GERATHERM MERCURY FREE GLASS THERMOMETER | 2019-02-21 The Geratherm mercury free oral glass thermometers are designed with an inner and outer barrel of glass. The inner barrel conta |
| 00614801200301 - GERATHERM MERCURY FREE GLASS ORAL THERMOMETER | 2019-02-21The 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. |
| 00614801200301 - GERATHERM MERCURY FREE GLASS ORAL THERMOMETER | 2019-02-21 The Geratherm mercury free oral glass thermometers are designed with an inner and outer barrel of glass. The inner barrel conta |
| 00614801200400 - GERATHERM MAGNATHERM MERCURY FREE GLASS THERMOMETER | 2019-02-21 MagnaTherm mercury free oral glass thermometers is designed with an inner and outer barrel of glass. The inner barrel contains |
| 20614801200411 - GERATHERM MAGNATHERM MERCURY CLINICAL FREE GLASS THERMOMETER | 2019-02-21 MagnaTherm Clinical mercury free oral glass thermometers is designed with an inner and outer barrel of glass. The inner barrel |
| 00614801200509 - GERATHERM MERCURY FREE GLASS THERMOMETER | 2019-02-21 The Geratherm mercury free rectal glass thermometers are designed with an inner and outer barrel of glass. The inner barrel con |
| 20614801200510 - GERATHERM MERCURY FREE GLASS THERMOMETER | 2019-02-21 The Geratherm mercury free rectal glass thermometers are designed with an inner and outer barrel of glass. The inner barrel con |
| 00614801200608 - GERATHERM MERCURY FREE BASAL GLASS THERMOMETER | 2019-02-21 Basal thermometer with magnifying case and pink retainer contains Galinstan, which is a non-toxic, liquid metal that replaces th |