FDA.reportPublic FDA data

Curaplex

Primary DI
00815277028820
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
590412
Catalog number
590412
Device description
Suction Kit - Easy Disposable Suction Unit W/ Adapter and Catheter
Published
2018-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OFOAirway suction kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFOAirway Suction KitAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810071639258PackageGS150In Commercial Distribution
00815277028820PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810071639258008100716392588100716392580810071639258
00815277028820008152770288208152770288200815277028820

GMDN Terms#

Term, Definition table
TermDefinition
First aid kit, non-medicated, single-useA convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a single-use 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
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
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30889483601208AirLife™Sunmed Group Holdings, LLCOFO2025-02-19
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10889483584422AirLife™AIRLIFEOFO2025-02-17
10889483584477AirLife™AIRLIFEOFO2025-02-17
30889483584143AirLife™Sunmed Group Holdings, LLCOFO2025-02-17
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30889483584181AirLife™Sunmed Group Holdings, LLCOFO2025-02-17
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10889483584439AirLife™AIRLIFEOFO2025-02-14
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30889483584433AirLife™Sunmed Group Holdings, LLCOFO2025-02-14
30889483584464AirLife™Sunmed Group Holdings, LLCOFO2025-02-14
10197106539682CARDINAL HEALTHCardinal Health 200, LLCOFO2024-01-23
50197106539680CARDINAL HEALTHCardinal Health 200, LLCOFO2024-01-23
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10190752117693AirLife™AIRLIFEOFO2022-09-05
50190752117684AirLife™VYAIRE MEDICAL, INC.OFO2022-09-05
50190752117691AirLife™VYAIRE MEDICAL, INC.OFO2022-09-05
10190752148901AirLife™AIRLIFEOFO2022-08-22
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10190752152045AirLife™AIRLIFEOFO2022-08-22