FDA UDI
In Commercial Distribution
🇺🇸 United States
POWER X2
DI: 00190790003210
·
Model: 0015816
·
FERNO-WASHINGTON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- POWER X2
- Primary DI
- 00190790003210
- Version / Model
- 0015816
- Catalog Number
- 0015816
- Company Name
- FERNO-WASHINGTON, INC.
- Labeler DUNS
- 004239034
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-10
- Public Version
- 1
- Public Version Date
- 2025-09-18
- Public Version Status
- New
- Public Device Record Key
- fa33e7b6-e90d-42c3-900b-45b11ee768df
Device Description
POWER X2
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
- Yes
- 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 |
|---|---|---|---|---|
| FPO | Stretcher, Wheeled | General Hospital | 880.6910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60487 | Ambulance stretcher, electrohydraulic | A battery-powered device consisting of a platform mounted on a wheeled frame, intended for use by emergency medical services (EMS) primarily to facilitate easy transport of a recumbent patient to and from ambulance vehicles (e.g., automobiles, aircraft, boats), whilst allowing the operator to raise and lower the platform using powered switches. It has an electrically-powered hydraulic undercarriage (e.g., X-frame) which can raise/lower the patient and is collapsible for ambulance loading; ambulance-mounted locking/docking devices may be included. The patient platform is typically hydraulically adjustable. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10190790003217 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 00190790003210 | GS1 |