FDA UDI
In Commercial Distribution
🇺🇸 United States
Meditherm
DI: B783704500170601129
·
Model: IRIS 640
·
Meditherm Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Meditherm
- Primary DI
- B783704500170601129
- Version / Model
- IRIS 640
- Catalog Number
- 1706400
- Company Name
- Meditherm Incorporated
- Labeler DUNS
- 118282031
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-25
- Public Version
- 1
- Public Version Date
- 2022-11-02
- Public Version Status
- New
- Public Device Record Key
- 363cf7f3-e25f-4254-b438-d07d7129408d
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LHQ | System, Telethermographic (Adjunctive Use) | Obstetrics/Gynecology | 884.2980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40803 | Infrared thermography system | A system using infrared photography or other infrared detection techniques to produce images or graphical representations of the distribution of body surface temperature for the purpose of diagnosing and assessing various conditions and disease states. Also referred to as a thermography scanner. This system typically consists of a camera display unit that includes a scanning-condensing optical system, infrared detector, an operator's console, photographic cameras, black-body phantom, electronic or computerized controls, software and an image display and analysis units. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B783704500170601129 | HIBCC |
Customer Contacts
- Phone
- 954 540 7633
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K003332 | 000 |