FDA.report

Curaplex

Primary DI
00810071631924
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
8600-01480
Catalog number
8600-01480
Device description
*Custom* Curaplex NPA Kit 4 Sizes w/ Lubricating Jelly
Published
2021-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
BTQAIRWAY, NASOPHARYNGEAL

Product Code Classifications

CodeDeviceSpecialtyClass
BTQAirway, NasopharyngealAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810071631924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810071631924008100716319248100716319240810071631924

GMDN Terms

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

Regulatory Flags

DUNS number
070556204
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
00199972000153Curaplex8600-015428600-015422026-01-23
00199972000160Curaplex8600-015438600-015432026-01-23
00199972000177Curaplex8600-015448600-015442026-01-23
00199972000184Curaplex8600-015458600-015452026-01-23
00199972000191Curaplex8600-015468600-015462026-01-23
00199972000207Curaplex8600-01546B8600-01546B2026-01-23
00199972000214Curaplex8600-015478600-015472026-01-23
00199972000221Curaplex8600-015488600-015482026-01-23
00199972000238Curaplex8600-015498600-015492026-01-23
00199972000016Curaplex Advanced Hemostatic Gauze4in x 4in (10cm x 10cm)CAHG-4X42025-12-17
00199972000030Curaplex Advanced Hemostatic Gauze3in x 1.6 Yds (7.6cm x 150 cm)CAHG-R52025-12-17
00199972000054Curaplex Advanced Hemostatic Gauze3in x 3.2Yds (7.6cm x 300 cm)CAHG-Z102025-12-17
00199972000078Curaplex®8600-015558600-015552025-12-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06979032640055GOBENHUZHOU JUNDA INDUSTRY CO., LTD.BTQ2025-08-26
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16920687310418MedisTianjin Medis Medical Device Co.,Ltd.BTQ2024-09-30
16920687310494MedisTianjin Medis Medical Device Co.,Ltd.BTQ2024-09-30
16920687310517MedisTianjin Medis Medical Device Co.,Ltd.BTQ2024-09-30
00612479273238McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273245McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273252McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273269McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
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00612479273320McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273344McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273368McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273382McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273405McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273429McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273443McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00810094576769CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576776CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576783CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576790CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576806CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576813CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576820CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576837CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576844CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576851CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576868CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30