FDA.reportPublic FDA data

Curaplex

Primary DI
00810094575878
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
1715-01827
Catalog number
1715-01827
Device description
Field 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
OTC
false
Sterile
false
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
00810094575878PackageGS125In Commercial Distribution
00810094575823PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094575878008100945758788100945758780810094575878
00810094575823008100945758238100945758230810094575823

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070556204
Device count
1
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00810094575830CuraplexBOUND 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
M68980820040Valkyrie LTOWB Collection SetSafeguard US Operating, LLCPOQ2021-07-19
M68980821040Valkyrie LTOWB Administration SetSafeguard US Operating, LLCPOQ2021-07-19
00812277037142CuraplexBOUND TREE MEDICAL, LLCPOQ2021-02-28
00842209118182NARNORTH AMERICAN RESCUE, LLCPOQ2021-02-08