| Primary Device ID | 00614801300605 |
| NIH Device Record Key | 7f3103cd-26e8-441f-a573-d06a3930c720 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Geratherm Baby ColorChoice Digital Thermometer |
| Version Model Number | Retail Pink Digital Thermometer w-backlight |
| Catalog Number | 30060 |
| Company DUNS | 928998905 |
| Company Name | R.G. ENTERPRISES (U.S.A.), INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | 00614801300605 [Primary] |
| FLL | Thermometer, Electronic, Clinical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| 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 | 2019-02-21 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 |