FDA.reportPublic FDA data

Curaplex

Primary DI
00815277027632
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
36709
Device description
Curaplex State Pen 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
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
CANREGULATOR, PRESSURE, GAS CYLINDER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CANRegulator, Pressure, Gas CylinderAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815277027632PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277027632008152770276328152770276320815277027632

GMDN Terms#

Term, Definition table
TermDefinition
First aid kit, non-medicated, reusableA convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070556204
Device count
1
DM exempt
false
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
false
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
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
00199972000153Curaplex8600-015428600-015422026-01-23
00199972000160Curaplex8600-015438600-015432026-01-23
00199972000177Curaplex8600-015448600-015442026-01-23
00199972000184Curaplex8600-015458600-015452026-01-23
00199972000191Curaplex8600-015468600-015462026-01-23
00199972000207Curaplex8600-01546B8600-01546B2026-01-23
00199972000214Curaplex8600-015478600-015472026-01-23
00199972000221Curaplex8600-015488600-015482026-01-23
00199972000238Curaplex8600-015498600-015492026-01-23
00199972000016Curaplex Advanced Hemostatic Gauze4in x 4in (10cm x 10cm)CAHG-4X42025-12-17
00199972000030Curaplex Advanced Hemostatic Gauze3in x 1.6 Yds (7.6cm x 150 cm)CAHG-R52025-12-17
00199972000054Curaplex Advanced Hemostatic Gauze3in x 3.2Yds (7.6cm x 300 cm)CAHG-Z102025-12-17
00199972000078Curaplex®8600-015558600-015552025-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850027043852Precision Medical Inc.Precision Medical, Inc.CAN2026-02-25
00819601025790Alcon Laboratories Inc.Airgas Therapeutics, LLCCAN2026-02-19
00848530108168RegulatorsSUNSET HEALTHCARE SOLUTIONS, INC.CAN2026-02-02
10848530108127RegulatorSUNSET HEALTHCARE SOLUTIONS, INC.CAN2026-01-26
10848530108158RegulatorSUNSET HEALTHCARE SOLUTIONS, INC.CAN2026-01-26
00199972000177CuraplexBOUND TREE MEDICAL, LLCCAN2026-01-23
00851440007483Responsive Respiratory, Inc.RESPONSIVE RESPIRATORY, INC.CAN2025-12-13
00848530107765Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.CAN2025-11-24
16977645350528XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350535XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350542SINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350559SINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350566SINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350573SINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350580SINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350597SINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350603XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350610XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350627XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350634XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350641XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350658XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
10848530107410React Regulator ValveSUNSET HEALTHCARE SOLUTIONS, INC.CAN2025-09-17
08592346978812MediVital EGCE, s.r.o.CAN2025-08-08
16977645350184SINYADanyang Xinya Valve Co., Ltd.CAN2025-06-16
16977645350276SINYADanyang Xinya Valve Co., Ltd.CAN2025-06-16
16977645350207SINYADanyang Xinya Valve Co., Ltd.CAN2025-06-16
16977645350214SINYADanyang Xinya Valve Co., Ltd.CAN2025-06-16
16977645350382SINYADanyang Xinya Valve Co., Ltd.CAN2025-06-16
16977645350399SINYADanyang Xinya Valve Co., Ltd.CAN2025-06-16