| Primary Device ID | 00614801200509 |
| NIH Device Record Key | 17d385e6-f56a-4175-a7d1-d8089f7c287e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GERATHERM MERCURY FREE GLASS THERMOMETER |
| Version Model Number | RETAIL GLASS RECTAL THERMOMETER |
| Catalog Number | 20050 |
| 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 | 00614801200509 [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 |
| 20614801200510 | The Geratherm mercury free rectal glass thermometers are designed with an inner and outer barrel |
| 00614801200509 | The Geratherm mercury free rectal glass thermometers are designed with an inner and outer barrel |
| 20614801200107 | The Geratherm mercury free oral glass thermometers are designed with an inner and outer barrel o |