| Primary Device ID | 20016944301060 |
| NIH Device Record Key | 3c991d71-b7cf-4319-8545-c803c82273b0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TempaDOT |
| Version Model Number | 5192R |
| Catalog Number | TD Plus F |
| Company DUNS | 030104165 |
| Company Name | MEDICAL INDICATORS INC |
| Device Count | 100 |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Weight | 0.0022 Pound |
| Weight | 0.0022 Pound |
| Weight | 0.0022 Pound |
| Weight | 0.0022 Pound |
| Weight | 0.0022 Pound |
| Weight | 0.0022 Pound |
| Weight | 0.0022 Pound |
| Weight | 0.0022 Pound |
| Weight | 0.0022 Pound |
| Weight | 0.0022 Pound |
| Weight | 0.0022 Pound |
| Weight | 0.0022 Pound |
| Weight | 0.0022 Pound |
| Weight | 0.0022 Pound |
| Weight | 0.0022 Pound |
| Weight | 0.0022 Pound |
| Weight | 0.0022 Pound |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00016944301066 [Primary] |
| GS1 | 10016944301063 [Unit of Use] |
| GS1 | 20016944301060 [Package] Contains: 00016944301066 Package: Case [1600 Units] In Commercial Distribution |
| FQZ | Thermometer, Clinical Color Change |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-08-23 |
| Device Publish Date | 2021-05-29 |
| 20016944301145 | TempaDOT C Non-Sterile Single use Clinical Thermometer |
| 20016944301138 | TempaDOT F Non-Sterile Single use Clinical Thermometer |
| 20016944301084 | TempaDOT C Sterile Single use Clinical Thermometer |
| 20016944301077 | TempaDOT Plus C single use clinical Thermometer with Rectal Sheath |
| 20016944301060 | TempaDOT Plus F single use Clinical Thermometer with Rectal Sheath |
| 20016944301053 | TempaDOT Bulk F Single Use Clinical Thermometer |
| 10016944301025 | TempaDOT F Sterile Single use Thermometer |
| 20016944301039 | TempaDOT F Non-Sterile single use Clinical thermometer |
| 20016944301022 | TempaDOT F Sterile Clinical single use thermometer |
| 20016944301008 | TempaDOT Axillary F Single use thermometer |