FDA.reportPublic FDA data

Curaplex

Primary DI
00815277028004
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
8600-01170
Device description
*Custom* NICU ET Tube 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
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
00815277028004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277028004008152770280048152770280040815277028004

GMDN Terms#

Term, Definition table
TermDefinition
Basic endotracheal tube, single-useA hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated. The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is typically made of plastic or rubber and is available in various diameters and lengths for adult and paediatric patients. This is a single-use 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
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
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
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