FDA UDI
In Commercial Distribution
🇺🇸 United States
Power PRO
DI: 07613327513264
·
Model: 6506
·
STRYKER CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Power PRO
- Primary DI
- 07613327513264
- Version / Model
- 6506
- Catalog Number
- 650605550002
- Company Name
- STRYKER CORPORATION
- Labeler DUNS
- 078470558
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-10
- Public Version
- 1
- Public Version Date
- 2020-09-18
- Public Version Status
- New
- Public Device Record Key
- 0ecdeb9a-c7f9-4703-a58c-f1614aaacd32
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
- No
- 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 |
|---|---|---|---|---|---|---|
| Primary | 07613327513264 | GS1 |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 93 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 93 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -30 – 130 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 130 Degrees Fahrenheit