FDA.reportPublic FDA data

Curaplex

Primary DI
00817617020389
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
680154-KIT
Catalog number
680154-KIT
Device description
Curaplex Epi Kit incl 1 cc Syringe w/25 ga x 1 in Needle
Published
2016-12-14
Public version status
Update
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
LRRFirst Aid Kit With Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRRFirst Aid Kit With DrugUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810094571894PackageGS175In Commercial Distribution
00817617020389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094571894008100945718948100945718940810094571894
00817617020389008176170203898176170203890817617020389

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe/needleA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
070556204
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
01999720000041Curaplex Advanced Hemostatic Gauze3in x 3.2Yds (7.6cm x 300 cm)CAHG-Z102025-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942509220548OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220555OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220562OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220579OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220630OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220654OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220661OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220678OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220739OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220753OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220760OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220777OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220784OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220807OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220814OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220821OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220838OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220845OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220852OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220869OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220876OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220883OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220920OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
06942509220937OP - First aid seriesYiwu Ori-Power Medtech Co.,Ltd.LRR2026-08-22
00766588260143Watercraft First Aid Kit - 16 Poly WhiteCertified Safety Manufacturing, Inc.LRR2026-08-19
00766588260181Teichert Clas A 21 - 18 MetalCertified Safety Manufacturing, Inc.LRR2026-08-19
00842209139682NARNORTH AMERICAN RESCUE, LLCLRR2026-08-19
00842209139699NARNORTH AMERICAN RESCUE, LLCLRR2026-08-19
00842209139712NARNORTH AMERICAN RESCUE, LLCLRR2026-08-19
00842209139729NARNORTH AMERICAN RESCUE, LLCLRR2026-08-19