CombiDiagnost R90
Basic Information
- Brand Name
- CombiDiagnost R90
- Primary DI
- 00884838101456
- Version / Model
- 709031
- Company Name
- Philips Medical Systems DMC GmbH
- Labeler DUNS
- 314101218
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-04
- Public Version
- 3
- Public Version Date
- 2023-11-08
- Public Version Status
- Update
- Public Device Record Key
- 757c31ed-c490-4c11-9016-5c0893b058c8
Device Description
The CombiDiagnost R90 is a multi-functional general Radiography/Fluoroscopy (R/F) system.that includes - Adjustable Straps for Patient Support; - Adult headrest; - Ankle Clamps; - Arm Support; - Babix holder vertical stand; - Compression Belt (singles. pull); - Console trolles; - Detector Holder for Patient Bed; - Extra Stitching Ruler; - Hand grips (Pair of); - Handle; - Infusion bottle holder; - Leg Supports (Pair of); - Mattress GXR Systems; - Mobile Detector Holder; - Monitor Ceiling Suspension(Family); - Monitor CS for1 Monitor; - Monitor CS for2 Monitors; - Monitor CS for3 Monitors; - Monitor Trolley Family: - Monitor Trolley for 1 Monitor assembly; - Monitor Trolley for 2 Monitors assembly; - Patient Support for Stitching; - Rotable stool for footrest; - Shoulder supports (Pair of); - Side Bar; - Stretch Grip for VS/VM Stand
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
- Yes
- 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 |
|---|---|---|---|---|
| JAA | System, x-ray, fluoroscopic, image-intensified | Radiology | 892.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61108 | Indirect flat panel x-ray detector | An electrically-powered, cassette-like device intended to be used as part of an x-ray system to detect x-ray images following exposure, and create a digital signal; it is not dedicated to imaging of a specific anatomy. It includes two types of transducing technology (i.e., indirect): a scintillator [e.g. caesium iodide (CsI)] screen converts x-ray energy into light, followed by the conversion of light into a digital signal by photodiode array. The image data can be sent to an appropriate processing unit through a wired or wireless connection (e.g., Wi-Fi). It may be used in place of a fixed detector in x-ray imaging systems, e.g., as part of a digital imaging conversion system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838101456 | GS1 |
Customer Contacts
- Phone
- +1(800)722-9377
- [email protected]