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
00812277034875Curaplex8600-013848600-013842019-07-01
00817617020488Curaplex8600-011938600-011932016-12-27
00817617020495Curaplex8600-011948600-011942016-12-27
00817617020501Curaplex8600-011958600-011952016-12-27
00812277036466Curaplex8600-014538600-014532020-12-30
00812277035230Curaplex1840-20142-A1840-20142-A2019-07-01
00815277020275Curaplex1840-201422016-12-14
00810094574765Curaplex301-670249-KIT301-670249-KIT2022-12-08
00810094576950CuraplexSIVSTTCHP-24-KITSIVSTTCHP-24-KIT2024-09-30
00810094576967CuraplexSIVSTGAHP-24-KITSIVSTGAHP-24-KIT2024-09-30
00810094576974CuraplexSIVSTTAHP-24-KITSIVSTTAHP-24-KIT2024-09-30
00810094577049Curaplex1840-012QM1840-012QM2024-09-30
00810094577056Curaplex1840-013QM1840-013QM2024-09-30
00810094577070Curaplex1840-010QM1840-010QM2024-09-30
00810094577087Curaplex1840-011QM1840-011QM2024-09-30
00810094577094Curaplex1840-014QM1840-014QM2024-09-30
00810094575960Curaplex8600-015138600-015132023-06-30
00810094575977Curaplex670268-KIT670268-KIT2023-06-30
00810094575984Curaplex8600-015148600-015142023-06-30
00812277035407Curaplex8600-014088600-014082019-08-30

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