FDA UDI
In Commercial Distribution
🇺🇸 United States
FUKUDA DENSHI
DI: 04538612912658
·
Model: BPU-100
·
FUKUDA DENSHI CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- FUKUDA DENSHI
- Primary DI
- 04538612912658
- Version / Model
- BPU-100
- Company Name
- FUKUDA DENSHI CO.,LTD.
- Labeler DUNS
- 690671011
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-15
- Public Version
- 2
- Public Version Date
- 2024-10-16
- Public Version Status
- Update
- Public Device Record Key
- b18021c0-a2a1-4ac0-b534-038312b61e3d
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 |
|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 870.1130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60387 | Noninvasive multiple cardiovascular measurement unit | An automated, mains electricity (AC-powered), portable electronic device designed to measure multiple cardiovascular parameters [including electrocardiogram (ECG), phonocardiogram (PCG), carotid pulse tracing, femoral pulse tracing and four limb pulse tracing/blood pressure] to assist in the diagnosis of cardiac and/or peripheral vascular disease. It typically consists of a control/analysis/display unit with cuffs, electrodes, audio and pressure sensors placed in strategic positions around the body. The device is typically operated by a healthcare professional. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04538612912658 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112521 | 000 |