FDA.reportPublic FDA data

Curaplex

Primary DI
00815277022149
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
73320XL
Device description
Curaplex Decontamination Personal Protection Kit, XL
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
false
Single use
true

Product Codes#

Code, Name table
CodeName
OKHBody fluids barrier kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKHBody Fluids Barrier KitGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810094572037PackageGS116In Commercial Distribution
00815277022149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094572037008100945720378100945720370810094572037
00815277022149008152770221498152770221490815277022149

GMDN Terms#

Term, Definition table
TermDefinition
Face splash shield, single-useA clear, transparent guard intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is commonly known as a splash shield. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

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
20809160388997Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2022-11-09
20809160365936Therma SolutionsMEDICAL ACTION INDUSTRIES INC.OKH2022-02-16
50749756915613DeRoyalDEROYAL INDUSTRIES, INC.OKH2021-08-23
50749756201075DeRoyalDEROYAL INDUSTRIES, INC.OKH2021-07-12
25060498452155Motion Medical DistributingHaslam Medical, Inc.OKH2021-02-15
25060498452094Motion Medical DistributingHaslam Medical, Inc.OKH2020-12-04
25060498452100Motion Medical DistributingHaslam Medical, Inc.OKH2020-12-04
25060498452117Motion Medical DistributingHaslam Medical, Inc.OKH2020-12-04
25060498452124Motion Medical DistributingHaslam Medical, Inc.OKH2020-12-04
20809160274030Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-12-13
20809160269098medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-11-01
20809160267025Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-10-16
20809160266882HalyardMEDICAL ACTION INDUSTRIES INC.OKH2019-10-14
20809160266899HALYARDMEDICAL ACTION INDUSTRIES INC.OKH2019-10-14
20809160261894Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-09-16
00815277028790CuraplexBOUND TREE MEDICAL, LLCOKH2018-12-15
00815277029544CuraplexBOUND TREE MEDICAL, LLCOKH2018-12-15
00815277029551CuraplexBOUND TREE MEDICAL, LLCOKH2018-12-15
00817617028675CuraplexBOUND TREE MEDICAL, LLCOKH2017-10-13
00817617028682CuraplexBOUND TREE MEDICAL, LLCOKH2017-10-13
00817617028699CuraplexBOUND TREE MEDICAL, LLCOKH2017-10-13
00817617028705CuraplexBOUND TREE MEDICAL, LLCOKH2017-10-13
20809160165871Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2017-10-09
00817617027722CuraplexBOUND TREE MEDICAL, LLCOKH2017-07-27
25060498451547Motion Medical DistributingHaslam Medical, Inc.OKH2017-06-13
25060498451516Motion Medical DistributingHaslam Medical, Inc.OKH2017-06-06
25060498451523Motion Medical DistributingHaslam Medical, Inc.OKH2017-06-06
20809160145484Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2017-04-21
25060498451349Motion Medical DistributingHaslam Medical, Inc.OKH2017-02-28
00815277020077CuraplexBOUND TREE MEDICAL, LLCOKH2016-12-14