FDA.reportPublic FDA data

Curaplex

Primary DI
00810071636363
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
2-0211-8130
Catalog number
2021-18130
Device description
Curaplex Select Nasopharyngeal Airway, 30 Fr, 7.5mm, Robertazzi Style, Latex Free, Sterile 10ea/bx
Published
2022-12-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTQAIRWAY, NASOPHARYNGEAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTQAirway, NasopharyngealAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810071637568PackageGS110In Commercial Distribution
00810071636363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810071637568008100716375688100716375680810071637568
00810071636363008100716363638100716363630810071636363

GMDN Terms#

Term, Definition table
TermDefinition
Nasopharyngeal airway, single-useA rubber or plastic tube that extends into the pharynx from either naris to maintain airway patency. The proximal end of the device may have an integral 22 mm connector for oxygen delivery. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
070556204
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
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
00612479273276McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273290McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273313McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273337McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273351McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273375McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273399McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273412McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273436McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00810094576639CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576646CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576653CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576660CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576677CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576684CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576691CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576707CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576714CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576721CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576738CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576745CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576752CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810003751034KENOREXKENTRON HEALTHCARE, INC.BTQ2024-04-14
00810003751041KENOREXKENTRON HEALTHCARE, INC.BTQ2024-04-14
00810003751058KENOREXKENTRON HEALTHCARE, INC.BTQ2024-04-14
00810003751065KENOREXKENTRON HEALTHCARE, INC.BTQ2024-04-14
00810003751072KENOREXKENTRON HEALTHCARE, INC.BTQ2024-04-14
00810003751089KENOREXKENTRON HEALTHCARE, INC.BTQ2024-04-14
00810003751096KENOREXKENTRON HEALTHCARE, INC.BTQ2024-04-14
00810003751102KENOREXKENTRON HEALTHCARE, INC.BTQ2024-04-14