| Primary Device ID | 00616784561332 |
| NIH Device Record Key | 4680e76a-5ba7-4ca6-aac4-bc8ad7d0f31c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Infrared Forehead Thermometer |
| Version Model Number | 5613 |
| Company DUNS | 008124539 |
| Company Name | DYNAREX CORPORATION |
| 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 | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00616784561325 [Primary] |
| GS1 | 00616784561332 [Package] Contains: 00616784561325 Package: [10 Units] In Commercial Distribution |
| 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 | 2016-09-24 |
| 00810180840163 - DynaSafety Cotton-Tipped Applicators in Sealed Vial,3" | 2024-11-19 |
| 00840117341210 - Medicine Cups 1oz | 2024-11-05 |
| 00840117312906 - Resp-O2 Endotracheal Tube Cuffed, 4.0 mm | 2024-11-01 Sterile-EO |
| 00840117312920 - Resp-O2 Endotracheal Tube Cuffed, 4.5 mm | 2024-11-01 Sterile-EO |
| 00840117317475 - Resp-O2 Endotracheal Tube Cuffed, 5.0 mm | 2024-11-01 Sterile-EO |
| 00840117312968 - Resp-O2 Endotracheal Tube Cuffed, 5.5 mm | 2024-11-01 Sterile-Eo |
| 00840117312982 - Resp-O2 Endotracheal Tube Cuffed, 6.0 mm | 2024-11-01 Sterile-Eo |
| 00840117313002 - Resp-O2 Endotracheal Tube Cuffed, 6.5 mm | 2024-11-01 Sterile-Eo |