FDA.report

Curaplex

Primary DI
00815277022019
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
683922
Device description
BTM RAPID TREATMENT KIT
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

Related Records

Product Codes

CodeName
OKHBody fluids barrier kit

Product Code Classifications

CodeDeviceSpecialtyClass
OKHBody Fluids Barrier KitGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815277022019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277022019008152770220198152770220190815277022019

GMDN Terms

TermDefinition
First aid kit, non-medicated, single-useA convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a single-use device.

Sterilization Methods

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 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 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