FDA.reportPublic FDA data

Curaplex

Primary DI
00815277021258
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
660424-500
Device description
Curaplex Combat Med Kit - FH (500ml NaCl)
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
FMFSyringe, piston
FOZCatheter,intravascular,therapeutic,short-term less than 30 days
LRSI.V. start kit
POQBlood transfusion kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2
LRSI.V. Start KitGeneral Hospital2
POQBlood Transfusion KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815277021258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277021258008152770212588152770212580815277021258

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral intravenous catheterization support kitA collection of noninvasive devices intended to prepare and/or dress a peripheral vein intravenous (IV) access site. It typically includes devices such as a tourniquet, disinfected swabs, dressings, tape, gauze, and gloves; neither the IV access device nor pharmaceuticals are included. It may also include short tubing and/or syringe, however it is not intended to directly conduct fluids from an IV administration bag/bottle (i.e., not an IV administration set). 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
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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Primary DI, Brand, Company table
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10653160393719MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-05-27
10840330704868ProCureTwin Med, LLCFMF2026-05-27
10840330704875ProCureTwin Med, LLCFMF2026-05-27
G001HSB1071191House Brand DentistryChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.FMF2024-06-05
07640138981593RegenKit-THT-3/RegenCell®REGEN LAB SAFMF2021-10-26
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08032248007291SOL CARE 1DELTA MED SPAFOZ2021-03-30
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G001S30000ShifengChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.FMF2020-11-17
08032248005372Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005389Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26