| Primary Device ID | 10814905020943 |
| NIH Device Record Key | 0cf20e59-80ee-4961-9366-f93f3cce0952 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Codonics DirectVista Thermal Film, 1436-DVB5 |
| Version Model Number | 1436-DVB5 |
| Company DUNS | 101533727 |
| Company Name | CODONICS 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 | true |
| Manufacturing Date | true |
| 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 |
| Phone | 4402431334 |
| support@codonics.com |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814905020946 [Primary] |
| GS1 | 10814905020943 [Package] Contains: 00814905020946 Package: CASE [4 Units] In Commercial Distribution |
| IWZ | Film, Radiographic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-13 |
| Device Publish Date | 2020-02-05 |
| 00814905020298 - Codonics Virtua® Controller - 73C | 2023-10-05 Virtua DICOM Server/Publisher Controller -73C |
| 00814905020304 - Codonics Virtua® XR Controller - 74C | 2023-10-05 Virtua XR DICOM Server/Publisher Controller -74C Device Level |
| 00814905020311 - Codonics Virtua® C Controller - 91C | 2023-10-05 Virtua E/C DICOM Server/Publisher Controller -91C |
| 00814905020328 - Codonics Virtua® Medical Disc Publisher | 2023-10-05 Integrated Virtua DICOM Server & Medical Disc (CD/DVD) Publisher System |
| 00814905020335 - Codonics Virtua® XR Medical Disc Publisher | 2023-10-05 Integrated Virtua XR DICOM Server & Medical Disc (CD/DVD) Publisher System |
| 00814905020342 - Codonics Virtua® C Controller - 90C | 2023-10-05 Virtua C DICOM Server/Publisher Controller -90C |
| 00814905020359 - Codonics Virtua® C/E Medical Disc Publisher | 2023-10-05 Integrated Virtua C/E DICOM Server & Medical Disc (CD/DVD) Publisher System |
| 00814905020380 - Codonics Virtua® Controller - 71C | 2023-10-05 Virtua DICOM Server/Publisher Controller -71C |