FDA.reportPublic FDA data

Curaplex

Primary DI
00815277022118
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
73320
Catalog number
73320
Device description
Curaplex Decontamination Personal Protection Kit, 2XL
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
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
00815277022118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277022118008152770221188152770221180815277022118

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical respirator, single-useA form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large particles (e.g., blood, body fluids, and airborne particulate materials) and small particles (e.g., bacteria and viruses) during medical, surgical, dental, and isolation procedures. It is typically made of multiple layers of non-woven polymers to produce a soft, flexible mask that will create an airtight seal against the user’s face and typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or an exhalation valve. 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
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
10809160388990Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2022-11-09
20809160388997Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2022-11-09
10809160365939Therma SolutionsMEDICAL ACTION INDUSTRIES INC.OKH2022-02-16
20809160365936Therma SolutionsMEDICAL ACTION INDUSTRIES INC.OKH2022-02-16
00810071632402CuraplexBOUND TREE MEDICAL, LLCOKH2021-09-30
00749756915618DeRoyalDEROYAL INDUSTRIES, INC.OKH2021-08-23
50749756915613DeRoyalDEROYAL INDUSTRIES, INC.OKH2021-08-23
00749756201070DeRoyalDEROYAL INDUSTRIES, INC.OKH2021-07-12
50749756201075DeRoyalDEROYAL INDUSTRIES, INC.OKH2021-07-12
15060498452158Motion Medical DistributingHaslam Medical, Inc.OKH2021-02-15
25060498452155Motion Medical DistributingHaslam Medical, Inc.OKH2021-02-15
15060498452097Motion Medical DistributingHaslam Medical, Inc.OKH2020-12-04
15060498452103Motion Medical DistributingHaslam Medical, Inc.OKH2020-12-04
15060498452110Motion Medical DistributingHaslam Medical, Inc.OKH2020-12-04
15060498452127Motion Medical DistributingHaslam Medical, Inc.OKH2020-12-04
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
10809160274033Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-12-13
20809160274030Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-12-13
10809160272589Medical Action Industries IncMEDICAL ACTION INDUSTRIES INC.OKH2019-11-22
10809160269091medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-11-01
20809160269098medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-11-01
10809160267028Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-10-16
20809160267025Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-10-16
10809160266885HalyardMEDICAL ACTION INDUSTRIES INC.OKH2019-10-14
10809160266892HALYARDMEDICAL ACTION INDUSTRIES INC.OKH2019-10-14
20809160266882HalyardMEDICAL ACTION INDUSTRIES INC.OKH2019-10-14
20809160266899HALYARDMEDICAL ACTION INDUSTRIES INC.OKH2019-10-14