Geratherm
Basal 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…
Basal 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.
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (3), Guangdong (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Ningbo Tianbo First AID Product Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 66 |
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
| China (Shenyang) MED-Land IMP/EXP Corp., Ltd. | Shanghai | Shanghai | Exporter | 32 |
| Jiangsu Prospect Healthcare Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 13 |
| JWD. Technologies (Jiangmen) Co., Ltd. | Jiangmen | Guangdong | Repacker / relabeller | 12 |
| DU-Hope International Group | Nanjing | Jiangsu | Contract manufacturer | 11 |
| Joytech Healthcare Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 9 |
| Kang ZE Industrial Co., Ltd. | Dongguan | Guangdong | Manufacturer | 3 |
Record
| Listed by | R.G. Enterprises (U.S.A.), Inc., United States |
|---|---|
| FDA product code | FLK |
| Device type | Thermometer, Clinical Mercury |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2920 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-01 |
| Record revised | 2019-02-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number |
| Packaging | Bag of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Clinical Basal Thermometer | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Geratherm Mercury Free Glass Thermometer | R.G. Enterprises (U.S.A.), Inc. | 3 |
| Disposable Thermometer Cover and Sheaths | Kang ZE Industrial Co., Ltd. | 3 |
| Bios Diagnostics | Thermor Ltd. | 1 |
| Geratherm Magnatherm Mercury Clinical Free Glass Thermometer | R.G. Enterprises (U.S.A.), Inc. | 1 |
| Geratherm Mercury Free Glass Hypothyroid Thermometer | R.G. Enterprises (U.S.A.), Inc. | 1 |
| Geratherm Magnatherm Mercury Free Glass Thermometer | R.G. Enterprises (U.S.A.), Inc. | 1 |
| Geratherm Mercury Free Basal Glass Thermometer | R.G. Enterprises (U.S.A.), Inc. | 1 |
| Geratherm Mercury Free Glass Oral Thermometer | R.G. Enterprises (U.S.A.), Inc. | 1 |
| Geratherm® classic | Geratherm AG | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.