FDA UDI
In Commercial Distribution
🇺🇸 United States
Sprint 100
DI: 08592654276013
·
Model: 1ES15409-257
·
L I N E T spol. s r.o.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sprint 100
- Primary DI
- 08592654276013
- Version / Model
- 1ES15409-257
- Company Name
- L I N E T spol. s r.o.
- Labeler DUNS
- 644544504
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-01
- Public Version
- 1
- Public Version Date
- 2021-04-09
- Public Version Status
- New
- Public Device Record Key
- 345298fc-f075-4226-b8ab-1b5d713d9460
Device Description
The sprint stretcher transport bed in its basic option used for transport and for x-ray scanning is designed for the transport critical patients being admitted in emergency conditions.
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 |
|---|---|---|---|---|
| 46148 | Patient transfer system, manual | A wheeled stretcher and a mechanism on which a patient can be placed so that the patient can be transferred with minimal disturbance (i.e., without changing horizontal body position, lifting, rolling, or dragging). The device typically includes a patient-transfer mechanism (e.g., mechanical, hydraulic) easy to operate by an attendant with minimal physical effort. It is used in hospitals and other healthcare facilities to reduce injuries to both patients and staff while transferring non-ambulatory, comatose, or neurologically-injured patients between beds, tables, and/or stretchers. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08592654276013 | GS1 |