FDA.reportPublic FDA data

Curaplex

Primary DI
00815277027700
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
660448-QC
Device description
*Custom* FBI SWAT Medic 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)
CBPValve, non-rebreathing
FMFSyringe, piston
KGZACCESSORIES, CATHETER
OGKOrotrachael intubation guide kit
OQUairway monitoring system
PEZCentral venous catheter dressing change kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2
CBPValve, Non-RebreathingAnesthesiology2
FMFSyringe, PistonGeneral Hospital2
KGZAccessories, CatheterGeneral, Plastic Surgery1
OGKOrotracheal Intubation Guide KitAnesthesiology2
OQUAirway Monitoring SystemAnesthesiology2
PEZCentral Venous Catheter Dressing Change KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815277027700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277027700008152770277008152770277000815277027700

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
Contains 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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08800052609303"Sure Fine Insulin Syringe 0.3cc 31G x 1/4"""SHINA MED CORPORATIONFMF2026-03-25
08800052609310"Sure Fine Insulin Syringe 0.3cc 31G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609327"Sure Fine Insulin Syringe 0.3cc 30g x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609334"Sure Fine Insulin Syringe 0.3cc 30G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609341"Sure Fine Insulin Syringe 0.5cc 31G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609358"Sure Fine Insulin Syringe 0.5cc 30G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609365"Sure Fine Insulin Syringe 0.5cc 30G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609372"Sure Fine Insulin Syringe 0.5cc 29G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609389"Sure Fine Insulin Syringe 1.0cc 31G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609396"Sure Fine Insulin Syringe 1.0cc 30g x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609402"Sure Fine Insulin Syringe 1.0cc 30G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609419"Sure Fine Insulin Syringe 1.0cc 29G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609426"Sure Fine Insulin Syringe 0.3cc 31G x 1/4"""SHINA MED CORPORATIONFMF2026-03-25
08800052609433"Sure Fine Insulin Syringe 0.3cc 31G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609440"Sure Fine Insulin Syringe 0.3cc 30g x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609457"Sure Fine Insulin Syringe 0.3cc 30G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609464"Sure Fine Insulin Syringe 0.5cc 31G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609471"Sure Fine Insulin Syringe 0.5cc 30G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609488"Sure Fine Insulin Syringe 0.5cc 30G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609495"Sure Fine Insulin Syringe 0.5cc 29G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609501"Sure Fine Insulin Syringe 1.0cc 31G x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609518"Sure Fine Insulin Syringe 1.0cc 30g x 5/16"""SHINA MED CORPORATIONFMF2026-03-25
08800052609525"Sure Fine Insulin Syringe 1.0cc 30G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
08800052609532"Sure Fine Insulin Syringe 1.0cc 29G x 1/2"""SHINA MED CORPORATIONFMF2026-03-25
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