FDA.reportPublic FDA data

Curaplex

Primary DI
00810071632006
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
8600-01479
Catalog number
8600-01479
Device description
*Custom* Curaplex THS Adult Intubation Kit
Published
2021-09-30
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
LNZChanger, tube, endotracheal

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810094572976PackageGS120In Commercial Distribution
00810071632006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094572976008100945729768100945729760810094572976
00810071632006008100716320068100716320060810071632006

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
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
00817617020518Curaplex8600-011968600-011962016-12-27
00812277034875Curaplex8600-013848600-013842019-07-01
00817617020488Curaplex8600-011938600-011932016-12-27
00817617020495Curaplex8600-011948600-011942016-12-27
00817617020501Curaplex8600-011958600-011952016-12-27
00812277036466Curaplex8600-014538600-014532020-12-30
00812277035230Curaplex1840-20142-A1840-20142-A2019-07-01
00815277020275Curaplex1840-201422016-12-14
00810094574765Curaplex301-670249-KIT301-670249-KIT2022-12-08
00810094576950CuraplexSIVSTTCHP-24-KITSIVSTTCHP-24-KIT2024-09-30
00810094576967CuraplexSIVSTGAHP-24-KITSIVSTGAHP-24-KIT2024-09-30
00810094576974CuraplexSIVSTTAHP-24-KITSIVSTTAHP-24-KIT2024-09-30
00810094577049Curaplex1840-012QM1840-012QM2024-09-30
00810094577056Curaplex1840-013QM1840-013QM2024-09-30
00810094577070Curaplex1840-010QM1840-010QM2024-09-30
00810094577087Curaplex1840-011QM1840-011QM2024-09-30
00810094577094Curaplex1840-014QM1840-014QM2024-09-30
00810094575960Curaplex8600-015138600-015132023-06-30
00810094575977Curaplex670268-KIT670268-KIT2023-06-30
00810094575984Curaplex8600-015148600-015142023-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810094575588CuraplexBOUND TREE MEDICAL, LLCLNZ2023-03-30
00810094574765CuraplexBOUND TREE MEDICAL, LLCLNZ2022-12-08
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
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