FDA.reportPublic FDA data

Curaplex

Primary DI
00812277035155
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
8600-01392
Catalog number
8600-01392
Device description
*Custom* MEMS EMS IV Start Kit
Published
2019-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LRSI.V. start kit
NGTSaline, vascular access flush
OJSTourniquet kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRSI.V. Start KitGeneral Hospital2
NGTSaline, Vascular Access FlushGeneral Hospital2
OJSTourniquet KitGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812277035155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812277035155008122770351558122770351550812277035155

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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199972000641Curaplex1015-471711015-471712026-10-15
00199972000672Curaplex1015-471721015-471722026-10-15
00199972000702Curaplex1015-471731015-471732026-10-15
00199972000733Curaplex1015-471741015-471742026-10-15
00199972000764Curaplex1015-471751015-471752026-10-15
00810094576615CuraplexSRxOD2SY-24-KITSRxOD2SY-24-KIT2024-03-30
00817617027630Curaplex1124-324001124-324002023-03-30
00810094574802Curaplex301-PrO2LT301-PrO2LT2023-04-10
00810094574819Curaplex301-PrO2LT-MSA301-PrO2LT-MSA2023-04-10
00810094574826Curaplex301-PrO2LTEZ-MM301-PrO2LTEZ-MM2023-04-10
00810094574833Curaplex301-PrO2LTEZ-MSA301-PrO2LTEZ-MSA2023-04-10
00810094574840Curaplex301-PrO2LTEZ301-PrO2LTEZ2023-04-10
00810094574857Curaplex301-PrO2LT-FM301-PrO2LT-FM2023-04-10
00810094574864Curaplex301-PrO2LT-0301-PrO2LT-02023-04-10
00810094574871Curaplex301-PrO2LTEZ-MF301-PrO2LTEZ-MF2023-04-10
00810094573072Curaplex301-44F10-120301-44F10-1202022-04-30
00810094573089Curaplex301-44F50-100301-44F50-1002022-04-30
00812277032024Curaplex301-44F50-100301-44F50-1002018-12-15
00812277032055Curaplex301-44F10-120301-44F10-1202018-12-15
00818834028356Curaplex301-12218301-122182022-04-30

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10653160395256CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRS2026-10-14
10198956585423CARDINAL HEALTHCardinal Health 200, LLCLRS2026-10-06
10198956588332CARDINAL HEALTHCardinal Health 200, LLCLRS2026-10-06
10809160539965Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.LRS2026-10-06
10653160393924MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-10-05
10653160393900MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-10-01
10198956570887CARDINAL HEALTHCardinal Health 200, LLCLRS2026-09-29
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10198956572256CARDINAL HEALTHCardinal Health 200, LLCLRS2026-09-25
10809160539019Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.LRS2026-09-25
10198956569799CARDINAL HEALTHCardinal Health 200, LLCLRS2026-09-22
10198956573758CARDINAL HEALTHCardinal Health 200, LLCLRS2026-09-22
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10198956559448CARDINAL HEALTHCardinal Health 200, LLCLRS2026-09-04
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