FDA.reportPublic FDA data

Curaplex

Primary DI
00817617023335
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
36111
Catalog number
36111
Device description
Pedi Board
Published
2017-09-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00817617023335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817617023335008176170233358176170233350817617023335

GMDN Terms#

Term, Definition table
TermDefinition
Head/neck immobilizer, reusableA rigid or non-rigid device, usually made of fabric and/or plastic materials, used to temporarily render the head/neck of a patient immovable to ensure immobilization when a head and/or spinal injury is suspected. It is used in conjunction with serious accidents and for transport of the patient on a stretcher and possibly in conjunction with a spinal board to which this device and the patient are strapped. It is typically made of x-ray translucent/non-ferromagnetically active materials that allow x-ray and magnetic resonance imaging (MRI) and comes in various sizes. This is a reusable device after appropriate cleaning.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070556204
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810094575809Curaplex680152-KIT680152-KIT2023-04-30
00815277028059Curaplex8600-ATFMLOK2016-12-14
00815277029377Curaplex680150-KIT680150-KIT2018-12-15
01999720000003Curaplex Advanced Hemostatic Gauze4in x 4in(10cm x 10cm)CAHG-4X42025-11-25
01999720000027Curaplex Advanced Hemostatic Gauze3in x 1.6 Yds (7.6cm x 150 cm)CAHG-R52025-11-25
01999720000041Curaplex Advanced Hemostatic Gauze3in x 3.2Yds (7.6cm x 300 cm)CAHG-Z102025-11-25
01999720000065Curaplex®8600-015558600-015552025-11-13
01999720000263Curaplex670070-KIT670070-KIT2025-11-25
00810071638619CURAPLEXS1137301-S11372023-03-30
00817617023052Curaplex3141-910103141-910102017-09-04
00817617023069Curaplex3141-910123141-910122017-09-04
00817617023083Curaplex3141-910143141-910142017-09-04
00199972000085Curaplex8600-015358600-015352026-01-23
00199972000092Curaplex8600-015368600-015362026-01-23
00199972000108Curaplex8600-015378600-015372026-01-23
00199972000115Curaplex8600-015388600-015382026-01-23
00199972000122Curaplex8600-015398600-015392026-01-23
00199972000139Curaplex8600-015408600-015402026-01-23
00199972000146Curaplex8600-015418600-015412026-01-23
00199972000153Curaplex8600-015428600-015422026-01-23

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
08057592700087HYBRIBOARDFLAMOR 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