FDA.reportPublic FDA data

HYBRIBOARD

Primary DI
08057592700087
Brand
HYBRIBOARD
Company
FLAMOR SRL
Model
SPORT
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.
Published
2025-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FPPStretcher, Hand-Carried

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPPStretcher, Hand-CarriedGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057592700087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057592700087080575927000878057592700087

GMDN Terms#

Term, Definition table
TermDefinition
Portable stretcherA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
629852208
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057592700025TOURNIK-ITTK-002025-05-28
08057592700032TOURNIK-ITTK-012025-05-28
08057592700049TOURNIK-ITTK-02T2025-05-28
08057592700070HYBRIBOARDEMS2025-05-23
08057592700094NECKLITEBLUE2025-01-27
08057592700100NECKLITEBLUE / SC2025-01-27
08057592700117NECKLITEYLW 2025-01-27
08057592700124NECKLITEYLW / SC2025-01-27
08057592700131NECKLITEBLK2025-01-27
08057592700148NECKLITEBLK / SC2025-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060950290000BabyPodADVANCED HEALTHCARE TECHNOLOGY LIMITEDFPP2026-04-27
05060950290017BabyPodADVANCED HEALTHCARE TECHNOLOGY LIMITEDFPP2026-04-27
05060950290031BabyPodADVANCED HEALTHCARE TECHNOLOGY LIMITEDFPP2026-04-27
05060950290086BabyPodADVANCED HEALTHCARE TECHNOLOGY LIMITEDFPP2026-04-27
05060950290338BabyPodADVANCED HEALTHCARE TECHNOLOGY LIMITEDFPP2026-04-27
05060950290345BabyPodADVANCED HEALTHCARE TECHNOLOGY LIMITEDFPP2026-04-27
05060950290352BabyPodADVANCED HEALTHCARE TECHNOLOGY LIMITEDFPP2026-04-27
06975575170073YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FPP2026-01-30
06975575170080YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FPP2026-01-30
06975675781957Rhino RescueEMSRUN GROUPFPP2025-10-30
06974679019639StretcherDragon Medical Co.,LtdFPP2025-08-27
06974442052160RED LEAFJiangsu Rixin Medical Equipment Co.,LtdFPP2025-05-23
06974442053242RED LEAFJiangsu Rixin Medical Equipment Co.,LtdFPP2025-05-23
08057592700070HYBRIBOARDFLAMOR SRLFPP2025-05-23
06974442054133RED LEAFJiangsu Rixin Medical Equipment Co.,LtdFPP2025-05-22
06974442058124RED LEAFJiangsu Rixin Medical Equipment Co.,LtdFPP2025-05-22
06974442051132RED LEAFJiangsu Rixin Medical Equipment Co.,LtdFPP2025-02-21
06974442051187RED LEAFJiangsu Rixin Medical Equipment Co.,LtdFPP2025-02-21
06974442055130RED LEAFJiangsu Rixin Medical Equipment Co.,LtdFPP2025-02-21
06974442055161RED LEAFJiangsu Rixin Medical Equipment Co.,LtdFPP2025-02-21
06974442058117RED LEAFJiangsu Rixin Medical Equipment Co.,LtdFPP2025-02-21
06974442058148RED LEAFJiangsu Rixin Medical Equipment Co.,LtdFPP2025-02-21
06974442051125RED LEAFJiangsu Rixin Medical Equipment Co.,LtdFPP2025-02-12
06974442051217RED LEAFJiangsu Rixin Medical Equipment Co.,LtdFPP2025-02-12
06974442051118RED LEAFJiangsu Rixin Medical Equipment Co.,LtdFPP2025-02-11
06974567747514RHINO RESCUEWuxi Emsrun Technology Co., Ltd.FPP2024-11-12
16974567747511RHINO RESCUEWuxi Emsrun Technology Co., Ltd.FPP2024-11-12
00810050863001AeroSled Turbo Sled (TS)LIFEPORT, LLCFPP2024-10-15
05060766500133XtractSRT.S.G. ASSOCIATES LLPFPP2024-09-04
05060766500140XtractSRT.S.G. ASSOCIATES LLPFPP2024-09-04