FDA UDI
In Commercial Distribution
🇺🇸 United States
HYBRIBOARD
DI: 08057592700087
·
Model: SPORT
·
FLAMOR SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- HYBRIBOARD
- Primary DI
- 08057592700087
- Version / Model
- SPORT
- Company Name
- FLAMOR SRL
- Labeler DUNS
- 629852208
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-23
- Public Version
- 1
- Public Version Date
- 2025-06-02
- Public Version Status
- New
- Public Device Record Key
- 6459473f-e27f-49be-88c8-1e3ba0e314f9
Device Description
The sides of the Hybriboard do not expose the patient to the risk of secondary damage caused, as is the case with basket stretchers, by the vertical walls of the stretcher being 20-25cm high.
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
- 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 |
|---|---|---|---|---|
| FPP | Stretcher, Hand-Carried | General Hospital | 880.6900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13818 | Portable stretcher | A manual device in the form of a portable lightweight platform or sheet with handles on which a patient can be carried in an emergency from an area inaccessible to a conventional ambulance stretcher. It may be designed as a folding stretcher, rescue backet, spine board, or evacuation sheet, and may include patient straps to secure/stabilize the patient. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08057592700087 | GS1 |