FDA UDI
In Commercial Distribution
🇺🇸 United States
CAREMIBRAIN
DI: 08437018413188
·
Model: FP-0600
·
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CAREMIBRAIN
- Primary DI
- 08437018413188
- Version / Model
- FP-0600
- Catalog Number
- FP-0600
- Company Name
- GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
- Labeler DUNS
- 463337670
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-28
- Public Version
- 1
- Public Version Date
- 2024-06-05
- Public Version Status
- New
- Public Device Record Key
- 9a25f03f-8d9b-446f-a390-e3c0ba7bc288
Device Description
CareMiBrain is a Positron Emission Tomography system for brain imaging in neurological and oncological applications. It has two main parts: the detection and acquisition system and the Control Unit.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | Radiology | 892.1200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60644 | Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use | A collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08437018413188 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232569 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 1776 | Millimeter | |
| Weight | 300 | Kilogram | |
| Width | 780 | Millimeter | |
| Depth | 203 | Millimeter | |
| Length | 2281 | Millimeter |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 70 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 55 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius