| Primary Device ID | 00614801200608 |
| NIH Device Record Key | 6627b22a-e490-4dd2-8f78-3505dbb618df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GERATHERM MERCURY FREE BASAL GLASS THERMOMETER |
| Version Model Number | RETAIL GLASS BASAL THERMOMETER with PINK COLORSTRI |
| Catalog Number | 20060 |
| 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 | 00614801200608 [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 |
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| 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 |
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| 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 | 2019-02-21Basal thermometer with magnifying case and pink retainer contains Galinstan, which is a non-toxic, liquid metal that replaces the toxic mercury. The expanded calibration strip provides an accurate temperature display with a magnifying (optical) case for easy temperature reading. It is suitable for oral or axillary temperature monitoring. Easy to clean or disinfect with alcohol or warm soapy water. Temperature measuring range is 97 degrees F to 101 degrees F. |
| 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 |