FDA.reportPublic FDA data

Curaplex

Primary DI
00815277023009
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
08-08011
Device description
Curaplex Select Ext Set, Bifuse, 8 in, 2 Luer Locking Site, 2 Slide Clamp, Spin Lock Connect 50ea/cs
Published
2016-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815277023009PackageGS150In Commercial Distribution
00815277022996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277023009008152770230098152770230090815277023009
00815277022996008152770229968152770229960815277022996

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
070556204
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00199972000153Curaplex8600-015428600-015422026-01-23
00199972000160Curaplex8600-015438600-015432026-01-23
00199972000177Curaplex8600-015448600-015442026-01-23
00199972000184Curaplex8600-015458600-015452026-01-23
00199972000191Curaplex8600-015468600-015462026-01-23
00199972000207Curaplex8600-01546B8600-01546B2026-01-23
00199972000214Curaplex8600-015478600-015472026-01-23
00199972000221Curaplex8600-015488600-015482026-01-23
00199972000238Curaplex8600-015498600-015492026-01-23
00199972000016Curaplex Advanced Hemostatic Gauze4in x 4in (10cm x 10cm)CAHG-4X42025-12-17
00199972000030Curaplex Advanced Hemostatic Gauze3in x 1.6 Yds (7.6cm x 150 cm)CAHG-R52025-12-17
00199972000054Curaplex Advanced Hemostatic Gauze3in x 3.2Yds (7.6cm x 300 cm)CAHG-Z102025-12-17
00199972000078Curaplex®8600-015558600-015552025-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810110920207IMed ProductsASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETIFPA2026-03-23
10810110920214IMed ProductsASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETIFPA2026-03-23
10810110920221IMed ProductsASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETIFPA2026-03-23
28699443581373FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETIFPA2026-03-13
28699443583261NeutrArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETIFPA2026-03-13
00850050080367iLet Insulin Infusion KitBeta Bionics, Inc.FPA2026-03-11
10801741239271MiniLocBard Access Systems, Inc.FPA2026-02-26
00850033629439Acta MedicalActa Medical LLCFPA2026-02-26
00850033629583Acta MedicalActa Medical LLCFPA2026-02-26
00850033629590Acta MedicalActa Medical LLCFPA2026-02-26
00813153027899CodanCodan US CorporationFPA2026-02-25
28699443582158NeutrArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETIFPA2026-02-16
00813153028124FRESENIUS KABICodan US CorporationFPA2026-02-05
00813153028131FRESENIUS KABICodan US CorporationFPA2026-02-05
00813153028148FRESENIUS KABICodan US CorporationFPA2026-02-05
00813153028155FRESENIUS KABICodan US CorporationFPA2026-02-05
B2125720502Male Luer Slip PlugINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700B2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700G2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700R2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700V2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700W2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700Y2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
00813153028179CodanCodan US CorporationFPA2026-01-21
10801741239189PowerLocBard Access Systems, Inc.FPA2026-01-20
10801741239196MiniLocBard Access Systems, Inc.FPA2026-01-20
10801741239202MiniLocBard Access Systems, Inc.FPA2026-01-20
10817708023418OPTFlowEMED TECHNOLOGIES CORPORATIONFPA2026-01-09
23661657080947NEUTRACLEAR BIDIRECTIONAL VALVE WITH PROTECTIVE CAPCAIR LGLFPA2026-01-01
2366165708095413,5 CM PE/PVC EXTENSION TUBING WITH 1 NEUTRACLEAR + 1 CLAMP + 1 MOBILE RINGCAIR LGLFPA2026-01-01