ProxiDiagnost N90
Basic Information
- Brand Name
- ProxiDiagnost N90
- Primary DI
- 00884838103221
- Version / Model
- 706110
- 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
- 2022-01-17
- Public Version
- 3
- Public Version Date
- 2024-01-25
- Public Version Status
- Update
- Public Device Record Key
- 84a016c4-49c8-4a37-8ae5-0a6a042de282
Device Description
The ProxiDiagnost N90 is a multi-functional general Radiography/ Fluoroscopy (R/F) system and includes • Footrest • Hand Grips Radiation Protection Accessories • Flexible Radiation Protection Apron • Front Radiation Protection Apron Additional Accessories (Optional) • Monitor Trolley • Monitor Ceiling Suspension • Parking Frame for Accessories • Shoulder Support • Side bar • Compression Belt • Adjustable Lateral Cassette Holder • Leg Supports • Infusion Bottle Holder • Arm Support for Catheterization • Ankle Clamps • Overhead Hand Grip • Adult Headrest • Mattress • Rotatable Stool for Footrest • Pediatric Micturition Set • Stretch Grip for Wall Stand • Bar Code Scanner • Patient Support • Stitching Ruler Accessories for the SkyPlate Detector (Optional) • Mobile Detector Holder • Detector Holder Patient Bed • Portable Panel Protector • Detector Handle • WPD Bags • Grids for SkyPlate Detector large
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
- 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 |
|---|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | Radiology | 892.1650 | 2 |
| KPR | System, X-Ray, Stationary | Radiology | 892.1680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37679 | Stationary general-purpose fluoroscopic x-ray system, digital | A stationary general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium. Images can be viewed in both real-time and delayed format. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838103221 | GS1 |