Meditherm 706400
GUDID B783706400170601160
Meditherm Digital Thermal Camera
Meditherm Incorporated
Infrared thermography system| Primary Device ID | B783706400170601160 |
| NIH Device Record Key | 6d457115-c7dd-406a-bfdf-c045e93216d7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Meditherm |
| Version Model Number | IRIS 640 |
| Catalog Number | 706400 |
| Company DUNS | 118282031 |
| Company Name | Meditherm Incorporated |
| 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 | true |
| Lot Batch | false |
| Serial Number | true |
| 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 | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B783706400170601160 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K003332
FDA Product Code
| LHQ | System, Telethermographic (Adjunctive Use) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-07 |
| Device Publish Date | 2024-02-28 |
On-Brand Devices [Meditherm]
| B7837064001 | Thermal Imaging Camera |
| B7837045001 | Thermal Imaging Camera |
| B7837045001705011327 | IRIS 450 |
| B7837045001705011226 | IRIS 450 |
| B783704500170501136 | IRIS 450 |
| B7837045001705011237 | IRIS 450 |
| B783704500170601177 | IRIS 640 |
| B783706400170601174 | IRIS 640 |
| B783704500170601129 | IRIS 640 |
| B783706400170601172 | IRIS 640 |
| B783704500170501138 | IRIS 450 |
| B783706400170601130 | Digital Thermal Camera |
| B783706400170601171 | Meditherm IRIS digital thermal camera |
| B783706400170601160 | Meditherm Digital Thermal Camera |
| B783706400170601127 | Meditherm Ditigal Thermal Camera |
| B783706400170601125 | Meditherm Thermal Imaging Camera |
| B783706400170601135 | Meditherm IRIS Digitel thermal camera |
| B783706400170601138 | Digital thermal camera |
Trademark Results [Meditherm]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MEDITHERM 75341071 not registered Dead/Abandoned |
TCP/RELIABLE INC. 1997-08-14 |
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