FDA.reportPublic FDA data

Curaplex

Primary DI
00815277020633
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
2525-16050
Device description
Curaplex ALS Pedi Kit For University Hosp of Cleveland
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)
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
DRXElectrode, electrocardiograph
DXQblood pressure cuff
FHMAPPARATUS, SUTURING, STOMACH AND INTESTINAL
FMFSyringe, piston
FMINeedle, hypodermic, single lumen
FPBFilter, infusion line
GJETRAY, BLOOD COLLECTION
MMKContainer, sharps
PEZCentral venous catheter dressing change kit
POQBlood transfusion kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2
DRXElectrode, ElectrocardiographCardiovascular2
DXQBlood Pressure CuffCardiovascular2
FHMApparatus, Suturing, Stomach And IntestinalGeneral, Plastic Surgery1
FMFSyringe, PistonGeneral Hospital2
FMINeedle, Hypodermic, Single LumenGeneral Hospital2
FPBFilter, Infusion LineGeneral Hospital2
GJETray, Blood CollectionClinical Chemistry2
MMKContainer, SharpsGeneral Hospital2
PEZCentral Venous Catheter Dressing Change KitGeneral Hospital2
POQBlood Transfusion KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815277020633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277020633008152770206338152770206330815277020633

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
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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