FDA.reportPublic FDA data

Curaplex

Primary DI
00815277021586
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
670064-KIT
Catalog number
670064-KIT
Device description
Curaplex IV Start Kit w/Tegaderm, 8 in Ext Set, 10ml Flush Syr, 2x2 Gauze, Alcohol Prep, TQ, Tape
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
FOZCatheter,intravascular,therapeutic,short-term less than 30 days
LRSI.V. start kit
POQBlood transfusion kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
00810094570736PackageGS150In Commercial Distribution
00815277021586PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094570736008100945707368100945707360810094570736
00815277021586008152770215868152770215860815277021586

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
00810094574765Curaplex301-670249-KIT301-670249-KIT2022-12-08
00810094576950CuraplexSIVSTTCHP-24-KITSIVSTTCHP-24-KIT2024-09-30
00810094576967CuraplexSIVSTGAHP-24-KITSIVSTGAHP-24-KIT2024-09-30
00810094576974CuraplexSIVSTTAHP-24-KITSIVSTTAHP-24-KIT2024-09-30
00810094577049Curaplex1840-012QM1840-012QM2024-09-30
00810094577056Curaplex1840-013QM1840-013QM2024-09-30
00810094577070Curaplex1840-010QM1840-010QM2024-09-30
00810094577087Curaplex1840-011QM1840-011QM2024-09-30
00810094577094Curaplex1840-014QM1840-014QM2024-09-30
00810094575960Curaplex8600-015138600-015132023-06-30
00810094575977Curaplex670268-KIT670268-KIT2023-06-30
00810094575984Curaplex8600-015148600-015142023-06-30
00812277035407Curaplex8600-014088600-014082019-08-30
00815277027243Curaplex533-MS-25058EA2016-12-16
00817617022758Curaplex533-MS-25058EA2017-02-06
00817617022918Curaplex533-MS-25058EA533-MS-25058EA2017-09-04
00817617022925Curaplex301-181EA301-181EA2017-12-22
00817617022949Curaplex301-180EA301-180EA2017-09-04
00815277025447Curaplex301-181EA2016-12-14
00815277027250Curaplex533-MS-25060EA2016-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956571235CARDINAL HEALTHCardinal Health 200, LLCLRS2026-10-23
10197344104178MEDLINEMEDLINE INDUSTRIES, INC.FOZ2026-10-16
10653160394877MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-10-15
00886333209859L-Cath PICCARGON MEDICAL DEVICES, INC.FOZ2026-10-14
10653160395065MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-10-14
10653160395225CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRS2026-10-14
10653160395256CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRS2026-10-14
04046955874330INTROCAN SAFETY®B. BRAUN MEDICAL INC.FOZ2026-10-11
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
10198956585447CARDINAL HEALTHCardinal Health 200, LLCLRS2026-09-29
00842209140220NARNORTH AMERICAN RESCUE, LLCLRS2026-09-28
00842209140244NARNORTH AMERICAN RESCUE, LLCPOQ2026-09-28
00842209140251NARNORTH AMERICAN RESCUE, LLCPOQ2026-09-28
00842209140268NARNORTH AMERICAN RESCUE, LLCPOQ2026-09-28
10801902226195ARROWTELEFLEX INCORPORATEDFOZ2026-09-28
10198956572256CARDINAL HEALTHCardinal Health 200, LLCLRS2026-09-25
10801902228205ARROWTELEFLEX INCORPORATEDFOZ2026-09-25
10801902228212ARROWTELEFLEX INCORPORATEDFOZ2026-09-25
10809160539019Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.LRS2026-09-25
10198956569799CARDINAL HEALTHCardinal Health 200, LLCLRS2026-09-22
10198956573758CARDINAL HEALTHCardinal Health 200, LLCLRS2026-09-22
10801902228717ARROWTELEFLEX INCORPORATEDFOZ2026-09-22
10809160538609HalyardMEDICAL ACTION INDUSTRIES INC.LRS2026-09-22
10809160536773HalyardMEDICAL ACTION INDUSTRIES INC.LRS2026-09-18
10809160536810HalyardMEDICAL ACTION INDUSTRIES INC.LRS2026-09-18