FDA.reportPublic FDA data

Curaplex

Primary DI
00815277022057
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
6840155STK
Device description
Curaplex Advanced Life Support (ALS) with Contents Pediatric Kit
Published
2016-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTMVentilator, emergency, manual (resuscitator)
BTRTube, tracheal (w/wo connector)
DRXElectrode, electrocardiograph
DXQblood pressure cuff
FMFSyringe, piston
FMINeedle, hypodermic, single lumen
FOZCatheter,intravascular,therapeutic,short-term less than 30 days
MMKContainer, sharps
OGKOrotrachael intubation guide kit
POQBlood transfusion kit
POZBiopsy needle kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2
DRXElectrode, ElectrocardiographCardiovascular2
DXQBlood Pressure CuffCardiovascular2
FMFSyringe, PistonGeneral Hospital2
FMINeedle, Hypodermic, Single LumenGeneral Hospital2
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2
MMKContainer, SharpsGeneral Hospital2
OGKOrotracheal Intubation Guide KitAnesthesiology2
POQBlood Transfusion KitGeneral Hospital2
POZBiopsy Needle KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815277022057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277022057008152770220578152770220570815277022057

GMDN Terms#

Term, Definition table
TermDefinition
First aid kit, non-medicated, reusableA convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817617020389Curaplex680154-KIT680154-KIT2016-12-14
00810071637285Curaplex301-P3050301-P3050EA2022-12-30
00810071637292CuraplexP3052EA301-P3052EA2022-12-30
00810071637308Curaplex301-P3054301-P3054EA2022-12-30
00199972000436Curaplex8600-01565-KIT8600-01565-KIT2026-08-15
00199972000443Curaplex670283-KIT670283-KIT2026-08-15
00199972000450Curaplex670284-KIT670284-KIT2026-08-15
00199972000467Curaplex8600-01567-KIT8600-01567-KIT2026-08-15
00199972000474Curaplex8600-01558-KIT8600-01558-KIT2026-08-15
00199972000528CuraplexSIVBDIO02-26-KITSIVBDIO02-26-KIT2026-08-15
00199972000535Curaplex670289-KIT670289-KIT2026-08-15
00199972000559Curaplex670290-KIT670290-KIT2026-08-15
00199972000573Curaplex670291-KIT670291-KIT2026-08-15
00810094578053Curaplex®SIVBDIO01-24-KITSIVBDIO01-24-KIT2026-07-30
00199972000504Curaplex8600-015668600-015662026-07-17
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

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05391530754279polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754286polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754323polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754385polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-09-27
05391530754415polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754477polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754484polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754651polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-09-27
05391530754736polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
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10801902228212ARROWTELEFLEX INCORPORATEDFOZ2026-09-25
10192253004489SharpSafetyCardinal Health 200, LLCMMK2026-09-24
10192253004502MonojectCardinal Health 200, LLCMMK2026-09-24
10192253004557MonojectCardinal Health 200, LLCMMK2026-09-24
10192253004571MonojectCardinal Health 200, LLCMMK2026-09-24
10192253004632SharpSafetyCardinal Health 200, LLCMMK2026-09-24
10192253005059MonojectCardinal Health 200, LLCFMI2026-09-24
10192253005080MonojectCardinal Health 200, LLCMMK2026-09-24
10192253005493MonojectCardinal Health 200, LLCMMK2026-09-24
10809160538913HalyardMEDICAL ACTION INDUSTRIES INC.FMI2026-09-24
16972857299252REDOX SMART PAN Pen NeedleSandstone Medical (Suzhou) Inc.FMI2026-09-24
10801902228717ARROWTELEFLEX INCORPORATEDFOZ2026-09-22
MHC18290272EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18310472EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22