FDA.reportPublic FDA data

Curaplex

Primary DI
00810094575830
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
1715-01837
Catalog number
1715-01837
Device description
Basic Blood Transfusion Kit
Published
2023-04-30
Public version status
New
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
POQBlood transfusion kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
POQBlood Transfusion KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810094575885PackageGS125In Commercial Distribution
00810094575830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094575885008100945758858100945758850810094575885
00810094575830008100945758308100945758300810094575830

GMDN Terms#

Term, Definition table
TermDefinition
Blood transfusion set, non-exchangeAn intravascular administration set intended to be used to administer blood from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device typically includes a needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, a stopcock, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an intravenous (IV) bag or other infusion fluid container. This is a single-use device.

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
00842209140244NARNORTH AMERICAN RESCUE, LLCPOQ2026-09-28
00842209140251NARNORTH AMERICAN RESCUE, LLCPOQ2026-09-28
00842209140268NARNORTH AMERICAN RESCUE, LLCPOQ2026-09-28
00850062467217Fresh Whole Blood Transfusion KitAltitude Technologies Inc.POQ2026-08-27
M68980820120Valkyrie LTOWB Collection SetSafeguard US Operating, LLCPOQ2026-01-22
M68980821110Valkyrie LTOWB Administration SetSafeguard US Operating, LLCPOQ2026-01-22
M68980801060Fresh Whole Blood Transfusion SetSafeguard US Operating, LLCPOQ2025-05-05
M68980821100Valkyrie LTOWB Administration SetSafeguard US Operating, LLCPOQ2024-12-27
M68980820110Valkyrie LTOWB Collection SetSafeguard US Operating, LLCPOQ2024-12-16
00850062467019Project Lavoy Blood KitAltitude Technologies Inc.POQ2024-06-19
00856767008045Training TMM-FBT-LTA (Tactical Medical Module-Field Blood Transfusion -Low TiterAltitude Technologies Inc.POQ2024-01-18
00842209128129NARNORTH AMERICAN RESCUE, LLCPOQ2023-08-10
00842209128198NARNORTH AMERICAN RESCUE, LLCPOQ2023-08-10
00810094575823CuraplexBOUND TREE MEDICAL, LLCPOQ2023-04-30
00810094575878CuraplexBOUND TREE MEDICAL, LLCPOQ2023-04-30
00810094575885CuraplexBOUND TREE MEDICAL, LLCPOQ2023-04-30
M68980820070Valkyrie LTOWB Collection SetSafeguard US Operating, LLCPOQ2022-11-04
M68980821070Valkyrie LTOWB Administration SetSafeguard US Operating, LLCPOQ2022-11-04
M68980801040Fresh Whole Blood Transfusion SetSafeguard US Operating, LLCPOQ2022-10-05
00842209124619NARNORTH AMERICAN RESCUE, LLCPOQ2022-08-31
M68980820060Valkyrie LTOWB Collection SetSafeguard US Operating, LLCPOQ2022-08-22
M68980821060Valkyrie LTOWB Administration SetSafeguard US Operating, LLCPOQ2022-08-22
M68980801050Fresh Whole Blood Transfusion SetSafeguard US Operating, LLCPOQ2022-08-09
M68980821050Valkyrie LTOWB Administration SetSafeguard US Operating, LLCPOQ2021-10-02
M68980820050Valkyrie LTOWB Collection SetSafeguard US Operating, LLCPOQ2021-10-02
M68980801030Fresh Whole Blood Transfusion SetSafeguard US Operating, LLCPOQ2021-10-01
00860000925310ForwardSynchronis Medical, LLCPOQ2021-09-17
00860000925372ForwardSynchronis Medical, LLCPOQ2021-09-17
00850015884009ForwardSYNCHRONIS MEDICAL, LLCPOQ2021-09-17
00850015884061ForwardSYNCHRONIS MEDICAL, LLCPOQ2021-09-17