FDA UDI
In Commercial Distribution
🇺🇸 United States
GI Genius
DI: 10884521821545
·
Model: CB1708-RFB
·
Covidien LP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GI Genius
- Primary DI
- 10884521821545
- Version / Model
- CB1708-RFB
- Company Name
- Covidien LP
- Labeler DUNS
- 058614483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-20
- Public Version
- 2
- Public Version Date
- 2023-09-04
- Public Version Status
- Update
- Public Device Record Key
- 919e1636-6bd1-4ad5-bcd1-be1369a0e136
Device Description
Intelligent Endoscopy Module , Refurbished
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
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| QNP | Gastrointesinal lesion software detection system | Gastroenterology, Urology | 876.1520 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64688 | Endoscopic video image interpretive unit | An electrically-powered computing unit intended to analyse endoscopic video images to automatically detect and localize suspected abnormalities and lesions (e.g., polyps) in real-time. It interfaces with an endoscopic video image processing unit and display monitor, and will typically use artificial intelligence (AI)/deep learning software to identify abnormalities and overlay visual flags/markers on video images to highlight regions of interest to clinicians. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10884521821545 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 14 – 104 Degrees Fahrenheit