FDA UDI
In Commercial Distribution
🇺🇸 United States
Power-LOAD
DI: 07613327394740
·
Model: 6390
·
STRYKER CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Power-LOAD
- Primary DI
- 07613327394740
- Version / Model
- 6390
- Catalog Number
- 639005550001
- Company Name
- STRYKER CORPORATION
- Labeler DUNS
- 078470558
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-15
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- d44a9299-73d1-4894-ae2e-a40607b33699
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
- 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 |
|---|---|---|---|---|
| 60488 | Ambulance stretcher loader | A battery-powered, hydraulically-operated device designed to be installed within an ambulance to support the loading and unloading of an ambulance stretcher, to improve the safety and ease of patient transfer to and from the ambulance. It is typically a semi-automated docking/locking, lifting, and conveying mechanism that may include additional guides and adaptors. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613327394740 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113598 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -30 – 158 Degrees Fahrenheit
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 93 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 158 Degrees Fahrenheit
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 93 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal