FDA UDI
In Commercial Distribution
🇺🇸 United States
FSN
DI: 00810000890576
·
Model: IPS100A
·
FORESEESON CUSTOM DISPLAYS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FSN
- Primary DI
- 00810000890576
- Version / Model
- IPS100A
- Catalog Number
- IPS100A
- Company Name
- FORESEESON CUSTOM DISPLAYS, INC.
- Labeler DUNS
- 029368094
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-27
- Public Version
- 1
- Public Version Date
- 2022-06-06
- Public Version Status
- New
- Public Device Record Key
- cba4b9c5-7423-4b1c-a721-f91fe6854af2
Device Description
Image Processing System
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | Radiology | 892.2020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36947 | Video image processor | A mains electricity (AC-powered) device designed to receive the electronic signals sent from a video camera for the purpose of editing and processing them into images. It may have additional features which compensate for/enhance the colour and light qualities provided. The picture images will typically be, e.g., a video recording of a magnetic resonance imaging (MRI) examination. Other forms of recording media may be used. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810000890576 | GS1 |
Customer Contacts
- Phone
- 714-300-0540
- [email protected]