FDA.reportPublic FDA data

Curaplex

Primary DI
00815277021234
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
660222
Device description
ADVANCED TRAUMA KIT - US EMBASSY
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)
DQAOximeter
DXQblood pressure cuff
FMFSyringe, piston
FOZCatheter,intravascular,therapeutic,short-term less than 30 days
FRODressing, wound, drug
GARSuture, nonabsorbable, synthetic, polyamide
HEBTAMPON, MENSTRUAL, UNSCENTED
MHCPORT, INTRAOSSEOUS, IMPLANTED
MMKContainer, sharps
NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
POQBlood transfusion kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2
DQAOximeterCardiovascular2
DXQBlood Pressure CuffCardiovascular2
FMFSyringe, PistonGeneral Hospital2
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2
FRODressing, Wound, DrugUnknownU
GARSuture, Nonabsorbable, Synthetic, PolyamideGeneral, Plastic Surgery2
HEBTampon, Menstrual, UnscentedObstetrics/Gynecology2
MHCNeedle, InterosseousGeneral Hospital2
MMKContainer, SharpsGeneral Hospital2
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2
POQBlood Transfusion KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815277021234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277021234008152770212348152770212340815277021234

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07757093013891SUTUMEDUnilene S.A.C.GAR2024-09-19
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07640121880988103149 Calibration GasSenTec AGDQA2024-07-05
07640121880995103164 tCOM+SenTec AGDQA2024-07-05
07640121881008103420 Sensor Adapter Cable (Regular)SenTec AGDQA2024-07-05
07640121881015103421 Sensor Adapter Cable (Long)SenTec AGDQA2024-07-05
07640121881022103422 Sensor Adapter Cable (Extra Long)SenTec AGDQA2024-07-05
G001HSB1071191House Brand DentistryChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.FMF2024-06-05
07640121881039Non-Adhesive WrapSenTec AGDQA2023-07-21
07757093013068SUTUMEDUnilene S.A.C.GAR2023-01-06
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07757093014096SUTUMEDUnilene S.A.C.GAR2023-01-06
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07757093014713SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014744SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014768SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014881SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014898SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014911SUTUMEDUnilene S.A.C.GAR2023-01-06
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