FDA.reportPublic FDA data

Curaplex

Primary DI
00815277028561
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
290025
Catalog number
290025
Device description
Curaplex Fluid Spill Kit
Published
2018-12-15
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
PXGSpill kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXGSpill KitGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810071639098PackageGS150In Commercial Distribution
00815277028561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810071639098008100716390988100716390980810071639098
00815277028561008152770285618152770285610815277028561

GMDN Terms#

Term, Definition table
TermDefinition
Infectious waste spill kitA set of devices used to clean up spillage of infectious material. It provides equipment and material for an appropriate method for removing the spillage, and includes the proper container for the disposal of the spillage. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070556204
Device count
1
DM exempt
true
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
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
00815277028578CuraplexBOUND TREE MEDICAL, LLCPXG2018-12-15
00842472106855MedStreamMEDICAL SPECIALTIES DISTRIBUTORS, LLCPXG2018-10-08
10842472106852MedStreamMEDICAL SPECIALTIES DISTRIBUTORS, LLCPXG2018-10-08
00842472106756MedStreamMEDICAL SPECIALTIES DISTRIBUTORS, LLCPXG2018-09-27
00842472106763MedStreamMEDICAL SPECIALTIES DISTRIBUTORS, LLCPXG2018-09-27
00842472106770MedStreamMEDICAL SPECIALTIES DISTRIBUTORS, LLCPXG2018-09-27
00842472106787MedStreamMEDICAL SPECIALTIES DISTRIBUTORS, LLCPXG2018-09-27
00842472106794MedStreamMEDICAL SPECIALTIES DISTRIBUTORS, LLCPXG2018-09-27
00842472106800MedStreamMEDICAL SPECIALTIES DISTRIBUTORS, LLCPXG2018-09-27
00842472106817MedStreamMEDICAL SPECIALTIES DISTRIBUTORS, LLCPXG2018-09-27
10842472106753MedStreamMEDICAL SPECIALTIES DISTRIBUTORS, LLCPXG2018-09-27
10842472106760MedStreamMEDICAL SPECIALTIES DISTRIBUTORS, LLCPXG2018-09-27
10842472106777MedStreamMEDICAL SPECIALTIES DISTRIBUTORS, LLCPXG2018-09-27
10842472106784MedStreamMEDICAL SPECIALTIES DISTRIBUTORS, LLCPXG2018-09-27
10842472106791MedStreamMEDICAL SPECIALTIES DISTRIBUTORS, LLCPXG2018-09-27
10842472106807MedStreamMEDICAL SPECIALTIES DISTRIBUTORS, LLCPXG2018-09-27
10842472106814MedStreamMEDICAL SPECIALTIES DISTRIBUTORS, LLCPXG2018-09-27
M752UPK1501Stradis Medical, LLC.STRADIS MEDICAL, LLCPXG2018-04-06
M752UPK1001Stradis Medical, LLC.STRADIS MEDICAL, LLCPXG2018-04-06
M752UPK2001Stradis Medical, LLC.STRADIS MEDICAL, LLCPXG2018-04-06
M752UPC2381Stradis Healthcare, LLCSTRADIS MEDICAL, LLCPXG2018-04-05
M752UPC2385Stradis Healthcare, LLCSTRADIS MEDICAL, LLCPXG2018-04-05
M752IM1300A1Stradis Medical, LLC.STRADIS MEDICAL, LLCPXG2018-01-04
M752IM1300A5Stradis Medical, LLC.STRADIS MEDICAL, LLCPXG2018-01-04
M752UPC2371Stradis Healthcare, LLCSTRADIS MEDICAL, LLCPXG2017-09-25