FDA.reportPublic FDA data

Curaplex

Primary DI
00815277029704
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
8600-01153
Catalog number
8600-01153
Device description
*Custom* Nassau County Personal Protection 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
PXCPersonal protection kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXCPersonal Protection KitGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815277029704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277029704008152770297048152770297040815277029704

GMDN Terms#

Term, Definition table
TermDefinition
Face splash shieldA 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
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
00842209136025NARNORTH AMERICAN RESCUE, LLCPXC2025-08-25
10194717120070Regard™ROI CPS, LLCPXC2024-10-02
10194717120131Regard™ROI CPS, LLCPXC2024-10-02
20194717120077Regard™ROI CPS, LLCPXC2024-10-02
20194717120138Regard™ROI CPS, LLCPXC2024-10-02
10194717119913Regard™ROI CPS, LLCPXC2024-08-14
20194717119910Regard™ROI CPS, LLCPXC2024-08-14
10194717119746Regard™ROI CPS, LLCPXC2024-06-20
20194717119743Regard™ROI CPS, LLCPXC2024-06-20
00842209130665NARNORTH AMERICAN RESCUE, LLCPXC2024-04-29
10194717116042Regard™ROI CPS, LLCPXC2022-07-11
20194717116049Regard™ROI CPS, LLCPXC2022-07-11
M7526892650STRADIS HEALTHCARESTRADIS MEDICAL, LLCPXC2022-03-21
M7526871050STRADIS HEALTHCARESTRADIS MEDICAL, LLCPXC2022-03-17
M7526894290STRADIS HEALTHCARESTRADIS MEDICAL, LLCPXC2022-03-14
M7526891530STRADIS HEALTHCARESTRADIS MEDICAL, LLCPXC2022-03-02
00612479259102McKessonMCKESSON MEDICAL-SURGICAL INC.PXC2022-02-03
00612479259126McKessonMCKESSON MEDICAL-SURGICAL INC.PXC2022-02-03
00612479259119McKessonMCKESSON MEDICAL-SURGICAL INC.PXC2022-02-03
00612479259133McKessonMCKESSON MEDICAL-SURGICAL INC.PXC2022-02-03
00816703025727MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-08-03
00840155403338MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-08-03
00840155403369MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-08-03
00816703025734MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-08-03
00840155403345MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-08-03
00840155403376MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-08-03
00816703028544MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-07-22
00816703028568MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-07-22
00816703028582MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-07-22
00816703028605MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-07-22