FDA UDI
In Commercial Distribution
🇺🇸 United States
FUKUDA DENSHI
DI: 04538612229589
·
Model: OAO-119A
·
FUKUDA DENSHI CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FUKUDA DENSHI
- Primary DI
- 04538612229589
- Version / Model
- OAO-119A
- Company Name
- FUKUDA DENSHI CO.,LTD.
- Labeler DUNS
- 690671011
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-31
- Public Version
- 2
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- df37a094-ecb0-47dc-9c82-b8ffbc5e20a1
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Cardiovascular | 870.1025 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36178 | Stretcher equipment holder | A device intended to be affixed to a stretcher and designed to provide a platform or holder for emergency equipment/devices during treatment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04538612229589 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150030 | 000 |