FDA UDI
In Commercial Distribution
🇺🇸 United States
Diagnostic X-ray Unit
DI: 08800040900009
·
Model: PXM-20BT PLUS
·
Poskom Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Diagnostic X-ray Unit
- Primary DI
- 08800040900009
- Version / Model
- PXM-20BT PLUS
- Company Name
- Poskom Co., Ltd.
- Labeler DUNS
- 688458491
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-15
- Public Version
- 2
- Public Version Date
- 2023-06-16
- Public Version Status
- Update
- Public Device Record Key
- 127aff1d-ce4a-4b59-aa17-fb8bf31c4dfd
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| IZL | System, X-Ray, Mobile | Radiology | 892.1720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37606 | Diagnostic x-ray system generator, portable | An x-ray generator with special size, weight, and power requirements that makes it suitable for use in a portable x-ray system, e.g., a system intended to be easily disassembled and reassembled at various locations. It is used to regulate incoming voltage and current in order to provide an x-ray tube with the power needed to produce an x-ray beam of the desired voltage (kV) and current (mA). This GMDN code includes transformer and inverter generator designs. Portable x-ray generators typically comprise a control assembly (console) and high voltage transformer assembly or are of a mono-tank generator design. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800040900009 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K032628 | 000 |