FDA.reportPublic FDA data

Curaplex

Primary DI
00815277022408
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
8600-0INTS0-1218
Device description
*Custom* Memphis Extension Set 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
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
00815277022408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277022408008152770224088152770224080815277022408

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070556204
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817617020389Curaplex680154-KIT680154-KIT2016-12-14
00810071637285Curaplex301-P3050301-P3050EA2022-12-30
00810071637292CuraplexP3052EA301-P3052EA2022-12-30
00810071637308Curaplex301-P3054301-P3054EA2022-12-30
00199972000436Curaplex8600-01565-KIT8600-01565-KIT2026-08-15
00199972000443Curaplex670283-KIT670283-KIT2026-08-15
00199972000450Curaplex670284-KIT670284-KIT2026-08-15
00199972000467Curaplex8600-01567-KIT8600-01567-KIT2026-08-15
00199972000474Curaplex8600-01558-KIT8600-01558-KIT2026-08-15
00199972000528CuraplexSIVBDIO02-26-KITSIVBDIO02-26-KIT2026-08-15
00199972000535Curaplex670289-KIT670289-KIT2026-08-15
00199972000559Curaplex670290-KIT670290-KIT2026-08-15
00199972000573Curaplex670291-KIT670291-KIT2026-08-15
00810094578053Curaplex®SIVBDIO01-24-KITSIVBDIO01-24-KIT2026-07-30
00199972000504Curaplex8600-015668600-015662026-07-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00810094575830CuraplexBOUND 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
M68980820040Valkyrie LTOWB Collection SetSafeguard US Operating, LLCPOQ2021-07-19
M68980821040Valkyrie LTOWB Administration SetSafeguard US Operating, LLCPOQ2021-07-19