FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DuraDiagnost Compact
DI: 00884838064737
·
Model: 989701001012
·
Philips Healthcare (Suzhou) Co., Ltd.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DuraDiagnost Compact
- Primary DI
- 00884838064737
- Version / Model
- 989701001012
- Catalog Number
- 712213
- Company Name
- Philips Healthcare (Suzhou) Co., Ltd.
- Labeler DUNS
- 421265537
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2023-08-03
- Public Version Status
- Update
- Public Device Record Key
- 56c21af6-5145-4ee4-83b3-cded9409ca90
- Distribution End Date
- 2019-08-31
Device Description
The DuraDiagnost Compact is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| KPR | System, x-ray, stationary | Radiology | 892.1680 | 2 |
| MQB | Solid state x-ray imager (flat panel/digital imager) | Radiology | 892.1680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37645 | Stationary basic diagnostic x-ray system, digital | An assembly of devices that comprise general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838064737 | GS1 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- 18 – 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal