FDA UDI
In Commercial Distribution
🇺🇸 United States
Hermia OLINDA
DI: 00859873006219
·
Model: 00859873006219
·
Hermes Medical Solutions AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hermia OLINDA
- Primary DI
- 00859873006219
- Version / Model
- 00859873006219
- Company Name
- Hermes Medical Solutions AB
- Labeler DUNS
- 354140220
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-10
- Public Version
- 1
- Public Version Date
- 2026-03-18
- Public Version Status
- New
- Public Device Record Key
- 6a6ba22e-a563-422d-b0a4-5277016bf3c3
Device Description
OLINDA/EXM® is a software application for nuclear medicine. Based on user input of time integrated activity in separate organs, OLINDA/EXM® calculates the organ dose and the whole-body dose and presents the results to the user. The results can be stored for future analysis. The dose estimates provided by OLINDA/EXM® may guide the decision making for future patient radionuclide therapy treatments or inform radiation protection measures for diagnostic radiopharmaceuticals.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| IYX | Camera, Scintillation (Gamma) | Radiology | 892.1100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40937 | Nuclear medicine system workstation | A freestanding, multi-purpose, image processing device that can be a component of one or more nuclear medicine imaging systems, e.g., a gamma camera, PET system or SPECT system. It is sometimes considered to be a component to a picture archiving and communication system (PACS). It does not contain the controls for the direct operation of the diagnostic imaging system. It can receive and transmit data both on-line and off-line and is typically located at a site remote from the operator's console. It has the capability to further process, manipulate and/or view patient images and information collected from one or more nuclear medicine based imaging systems. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859873006219 | GS1 |