FDA.reportPublic FDA data

Curaplex

Primary DI
00817617028842
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
8600-01263
Catalog number
8600-01263
Device description
*Custom* Curaplex Opioid Overdose Kit, Indian River Sheriff's Office
Published
2017-12-12
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
CCTAPPLICATOR (LARYNGO-TRACHEAL), TOPICAL ANESTHESIA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCTApplicator (Laryngo-Tracheal), Topical AnesthesiaAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817617028842PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817617028842008176170288428176170288420817617028842

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary resuscitation mask, single-useA flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS) or as part of first aid kits. 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
14026704709868LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2023-08-31
14026704709875LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2023-08-31
14026704709882LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2023-08-31
34026704709862LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2023-08-31
24026704709872LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2023-08-31
24026704709889LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2023-08-31
00841470100315DART-ReachPULMODYNE INCCCT2022-03-25
00841470100322DART-ReachPULMODYNE INCCCT2022-03-25
00841470100339DART-ReachPULMODYNE INCCCT2022-03-25
00841470103804DART-ReachENGINEERED MEDICAL SYSTEMS INCCCT2022-03-25
00841470103811DART-ReachENGINEERED MEDICAL SYSTEMS INCCCT2022-03-25
00841470103828DART-ReachENGINEERED MEDICAL SYSTEMS INCCCT2022-03-25
10841470100312DART-ReachPULMODYNE INCCCT2022-03-25
10841470100329DART-ReachPULMODYNE INCCCT2022-03-25
10841470100336DART-ReachPULMODYNE INCCCT2022-03-25
10841470103801DART-ReachENGINEERED MEDICAL SYSTEMS INCCCT2022-03-25
10841470103818DART-ReachENGINEERED MEDICAL SYSTEMS INCCCT2022-03-25
10841470103825DART-ReachENGINEERED MEDICAL SYSTEMS INCCCT2022-03-25
14026704717535LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2020-07-30
14026704717542LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2020-07-30
14026704717559LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2020-07-30
24026704717532LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2020-07-30
34026704717546LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2020-07-30
34026704717553LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2020-07-30
00815277029407CuraplexBOUND TREE MEDICAL, LLCCCT2018-12-15
00817617029924CuraplexBOUND TREE MEDICAL, LLCCCT2018-12-15
14026704613219LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2017-10-27
34026704613213LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2017-10-27
14026704613196LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2017-09-25
14026704613226LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2017-09-25