FDA.report

Curaplex

Primary DI
00817617026183
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
2021-15034
Catalog number
2021-15034
Device description
Curaplex Nasopharyngeal Airway, Latex-Free, PVC, 34 FR
Published
2017-09-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
BTQAIRWAY, NASOPHARYNGEAL

Product Code Classifications

CodeDeviceSpecialtyClass
BTQAirway, NasopharyngealAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817617026183PackageGS110In Commercial Distribution
00817617026961PackageGS110In Commercial Distribution
00817617025810PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817617026183008176170261838176170261830817617026183
00817617026961008176170269618176170269610817617026961
00817617025810008176170258108176170258100817617025810

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
Ethylene Oxide

Regulatory Flags

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

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

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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
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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