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
00815277027243Curaplex533-MS-25058EA2016-12-16
00817617022758Curaplex533-MS-25058EA2017-02-06
00817617022918Curaplex533-MS-25058EA533-MS-25058EA2017-09-04
00817617022925Curaplex301-181EA301-181EA2017-12-22
00817617022949Curaplex301-180EA301-180EA2017-09-04
00815277025447Curaplex301-181EA2016-12-14
00815277027250Curaplex533-MS-25060EA2016-12-14
00810071630972Curaplex301-101EA301-101EA2022-12-30
00817617022888Curaplex301-107EA301-107EA2017-09-13
00817617022895Curaplex301-100EA301-100EA2017-09-13
00810071638688Curaplex301-FO-MIL-000301-FO-MIL-0002026-10-21
00199972000641Curaplex1015-471711015-471712026-10-15
00199972000672Curaplex1015-471721015-471722026-10-15
00199972000702Curaplex1015-471731015-471732026-10-15
00199972000733Curaplex1015-471741015-471742026-10-15
00199972000764Curaplex1015-471751015-471752026-10-15
00810094576615CuraplexSRxOD2SY-24-KITSRxOD2SY-24-KIT2024-03-30
00817617027630Curaplex1124-324001124-324002023-03-30
00810094574802Curaplex301-PrO2LT301-PrO2LT2023-04-10
00810094574819Curaplex301-PrO2LT-MSA301-PrO2LT-MSA2023-04-10

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