FDA.reportPublic FDA data

Curaplex

Primary DI
00812277035100
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
8600-01393
Catalog number
8600-01393
Device description
State of Nevada OEMS Pediatric ALS
Published
2019-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
BTMVentilator, emergency, manual (resuscitator)
BYGMASK, OXYGEN
CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
CATCANNULA, NASAL, OXYGEN
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
DRXElectrode, electrocardiograph
DXQblood pressure cuff
FMFSyringe, piston
FMINeedle, hypodermic, single lumen
FOZCatheter, intravascular, therapeutic, short-term less than 30 days
FPASet, administration, intravascular
FPKTubing, fluid delivery
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
JOLCATHETER AND TIP, SUCTION
KGBMASK, OXYGEN, NON-REBREATHING
LDESTETHOSCOPE, MANUAL
LRSI.V. start kit
MMKContainer, sharps
NODBoard, arm (with cover), non-sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2
BYGMask, OxygenAnesthesiology1
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1
CATCannula, Nasal, OxygenAnesthesiology1
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2
DRXElectrode, ElectrocardiographCardiovascular2
DXQBlood Pressure CuffCardiovascular2
FMFSyringe, PistonGeneral Hospital2
FMINeedle, Hypodermic, Single LumenGeneral Hospital2
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2
FPASet, Administration, IntravascularGeneral Hospital2
FPKTubing, Fluid DeliveryGeneral Hospital2
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1
JOLCatheter And Tip, SuctionGeneral Hospital2
KGBMask, Oxygen, Non-RebreathingAnesthesiology1
LDEStethoscope, ManualCardiovascular1
LRSI.V. Start KitGeneral Hospital2
MMKContainer, SharpsGeneral Hospital2
NODBoard, Arm (With Cover), Non-SterileGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812277035100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812277035100008122770351008122770351000812277035100

GMDN Terms#

Term, Definition table
TermDefinition
First aid kit, non-medicated, single-useA 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 single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070556204
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
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
00817617023335Curaplex36111361112017-09-04
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

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