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
00199972000641Curaplex1015-471711015-471712026-10-15
00199972000672Curaplex1015-471721015-471722026-10-15
00199972000702Curaplex1015-471731015-471732026-10-15
00199972000733Curaplex1015-471741015-471742026-10-15
00199972000764Curaplex1015-471751015-471752026-10-15
00810094576615CuraplexSRxOD2SY-24-KITSRxOD2SY-24-KIT2024-03-30
00817617027630Curaplex1124-324001124-324002023-03-30
00810094574802Curaplex301-PrO2LT301-PrO2LT2023-04-10
00810094574819Curaplex301-PrO2LT-MSA301-PrO2LT-MSA2023-04-10
00810094574826Curaplex301-PrO2LTEZ-MM301-PrO2LTEZ-MM2023-04-10
00810094574833Curaplex301-PrO2LTEZ-MSA301-PrO2LTEZ-MSA2023-04-10
00810094574840Curaplex301-PrO2LTEZ301-PrO2LTEZ2023-04-10
00810094574857Curaplex301-PrO2LT-FM301-PrO2LT-FM2023-04-10
00810094574864Curaplex301-PrO2LT-0301-PrO2LT-02023-04-10
00810094574871Curaplex301-PrO2LTEZ-MF301-PrO2LTEZ-MF2023-04-10
00810094573072Curaplex301-44F10-120301-44F10-1202022-04-30
00810094573089Curaplex301-44F50-100301-44F50-1002022-04-30
00812277032024Curaplex301-44F50-100301-44F50-1002018-12-15
00812277032055Curaplex301-44F10-120301-44F10-1202018-12-15
00818834028356Curaplex301-12218301-122182022-04-30

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