FDA.reportPublic FDA data

Curaplex

Primary DI
00815277021142
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
531503P
Device description
Curaplex CPAP Kit w/Bag, Regulator and Cylinder
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
BTLVentilator, emergency, powered (resuscitator)
BYEAttachment, breathing, positive end expiratory pressure
BYXTUBING, PRESSURE AND ACCESSORIES
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
CANREGULATOR, PRESSURE, GAS CYLINDER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTLVentilator, Emergency, Powered (Resuscitator)Anesthesiology2
BYEAttachment, Breathing, Positive End Expiratory PressureAnesthesiology2
BYXTubing, Pressure And AccessoriesAnesthesiology1
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2
CANRegulator, Pressure, Gas CylinderAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815277021142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277021142008152770211428152770211420815277021142

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary resuscitation kit, reusableA collection of items in a portable case intended for cardiopulmonary resuscitation (e.g., emergency pharmaceuticals, airway tubes, face masks or resuscitator). It is typically placed in a convenient location in public buildings and in EMS vehicles for quick access in emergency situations. This is a reusable 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
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
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08056814676261DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676377DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676384DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676391DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676407DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676230DIMARHMC PREMEDICAL SPABZD2025-03-20
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