| Primary Device ID | 10852282007157 |
| NIH Device Record Key | d9e61c68-3a24-470a-8230-f760f47beabf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Safe-T-Vue 6 |
| Version Model Number | STV6 |
| Catalog Number | 7206-50 |
| Company DUNS | 152578522 |
| Company Name | Temptime Corporation |
| Device Count | 50 |
| 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 | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 973-630-6000 |
| info@temptimecorp.com |
| Storage Environment Temperature | Between 1 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852282007150 [Unit of Use] |
| GS1 | 10852282007157 [Primary] |
| GS1 | 20852282007154 [Package] Package: Case of 200 [4 Units] In Commercial Distribution |
| KSS | Supplies, Blood-Bank |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-06 |
| Device Publish Date | 2019-10-29 |
| 20852282007147 - Safe-T-Vue 10 | 2019-11-06 A blood bag temperature monitor for use by health care providers to determine if blood or blood products have reached or exceede |
| 10852282007157 - Safe-T-Vue 6 | 2019-11-06A blood bag temperature monitor for use by health care providers to determine if blood or blood products have reached or exceeded the indication temperature. |
| 10852282007157 - Safe-T-Vue 6 | 2019-11-06 A blood bag temperature monitor for use by health care providers to determine if blood or blood products have reached or exceede |
| 00852282007006 - HEATmarker® Time-Temperature Indicators: F3 | 2019-02-21 Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed t |
| 00852282007013 - HEATmarker® Time-Temperature Indicators: F6 | 2019-02-21 Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed t |
| 00852282007020 - HEATmarker® Time-Temperature Indicators: F9 | 2019-02-21 Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed t |
| 00852282007037 - HEATmarker® Time-Temperature Indicators: F12 | 2019-02-21 Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed t |
| 00852282007044 - HEATmarker® Time-Temperature Indicators: F24 | 2019-02-21 Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed t |
| 00852282007051 - HEATmarker® Time-Temperature Indicators: F36 | 2019-02-21 Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed t |