FDA.reportPublic FDA data

Curaplex

Primary DI
00810094574765
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
301-670249-KIT
Catalog number
301-670249-KIT
Device description
Curaplex THS Accucuff Kit
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LNZChanger, tube, endotracheal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNZChanger, Tube, EndotrachealAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810094574765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094574765008100945747658100945747650810094574765

GMDN Terms#

Term, Definition table
TermDefinition
Airway pressure monitor, non-poweredA mechanical device designed to provide a visual indication of a patient's airway pressure during ventilation. It is typically contained in a clear housing marked with a pressure scale [e.g., 5 to 60 cm H20 (hPa)], and has a spring-loaded indicator that, in resistance to the expiratory flow of air, registers the airway pressure. It connects to the manometer port of a variety of ventilation devices such as a resuscitation bag, hyperinflation bag, continuous positive airway pressure (CPAP) mask, or a CPAP circuit. It may be used in a healthcare setting (including ambulatory) or in the home. This is a single-use device.

Regulatory Flags#

DUNS number
070556204
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
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
00810094575588CuraplexBOUND TREE MEDICAL, LLCLNZ2023-03-30
00810071633133CuraplexBOUND TREE MEDICAL, LLCLNZ2022-03-31
00810071633140CuraplexBOUND TREE MEDICAL, LLCLNZ2022-03-31
00810071633157CuraplexBOUND TREE MEDICAL, LLCLNZ2022-03-31
00810071633164CuraplexBOUND TREE MEDICAL, LLCLNZ2022-03-31
00810071633171CuraplexBOUND TREE MEDICAL, LLCLNZ2022-03-31
00810071633188CuraplexBOUND TREE MEDICAL, LLCLNZ2022-03-31
00810071633195CuraplexBOUND TREE MEDICAL, LLCLNZ2022-03-31
00810071632006CuraplexBOUND TREE MEDICAL, LLCLNZ2021-09-30
00812277036022CuraplexBOUND TREE MEDICAL, LLCLNZ2019-12-30
00815277020008CuraplexBOUND TREE MEDICAL, LLCLNZ2016-12-14
00815277020015CuraplexBOUND TREE MEDICAL, LLCLNZ2016-12-14
00815277020022CuraplexBOUND TREE MEDICAL, LLCLNZ2016-12-14
00815277020039CuraplexBOUND TREE MEDICAL, LLCLNZ2016-12-14
00815277020497CuraplexBOUND TREE MEDICAL, LLCLNZ2016-12-14
00815277020503CuraplexBOUND TREE MEDICAL, LLCLNZ2016-12-14
00815277020589CuraplexBOUND TREE MEDICAL, LLCLNZ2016-12-14
00815277020794CuraplexBOUND TREE MEDICAL, LLCLNZ2016-12-14
00815277027465CuraplexBOUND TREE MEDICAL, LLCLNZ2016-12-14
00815277028004CuraplexBOUND TREE MEDICAL, LLCLNZ2016-12-14
M996JEM3250JEM 325 Endotracheal Tube ChangerINSTRUMENTATION INDUSTRIES, INCORPORATEDLNZ2016-09-24
M996JEM3300JEM 330 Endotracheal Tube ChangerINSTRUMENTATION INDUSTRIES, INCORPORATEDLNZ2016-09-24
M996JEM3400JEM 340 Endotracheal Tube ChangerINSTRUMENTATION INDUSTRIES, INCORPORATEDLNZ2016-09-24
M996JEM3500JEM 350 Endotracheal Tube ChangerINSTRUMENTATION INDUSTRIES, INCORPORATEDLNZ2016-09-24
M996JEM3550JEM 355 Endotracheal Tube ChangerINSTRUMENTATION INDUSTRIES, INCORPORATEDLNZ2016-09-24
M996JEM3600JEM 360 Endotracheal Tube ChangerINSTRUMENTATION INDUSTRIES, INCORPORATEDLNZ2016-09-24
M996JEM3650JEM 365 Endotracheal Tube ChangerINSTRUMENTATION INDUSTRIES, INCORPORATEDLNZ2016-09-24
M996JEM3700JEM 370 Endotracheal Tube ChangerINSTRUMENTATION INDUSTRIES, INCORPORATEDLNZ2016-09-24
M996JEM4000JEM 400 Endotracheal Tube ChangerINSTRUMENTATION INDUSTRIES, INCORPORATEDLNZ2016-09-24
M996JEM4010JEM 401 Set of Endotracheal Tube Changers, (includes 9 sizes)INSTRUMENTATION INDUSTRIES, INCORPORATEDLNZ2016-09-24