FDA.reportPublic FDA data

Curaplex

Primary DI
00810094575588
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
8600-01512
Catalog number
8600-01512
Device description
*CUSTOM* Curaplex Brigham Intubation Kit
Published
2023-03-30
Public version status
New
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
LNZChanger, tube, endotracheal
OGHLaryngoscope kit
OGKOrotracheal intubation guide kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNZChanger, Tube, EndotrachealAnesthesiology2
OGHLaryngoscope KitAnesthesiology1
OGKOrotracheal Intubation Guide KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810094575588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094575588008100945755888100945755880810094575588

GMDN Terms#

Term, Definition table
TermDefinition
Rigid intubation laryngoscope, single-useA hand-held disposable device intended to be used by anaesthesia/emergency service personnel to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It has a handle containing batteries to power its light (a small built-in light bulb or fibreoptic light) for airway illumination, and a curved or straight blade of various designs and lengths that can be hinged/interchanged or integral. Some types are magnetic resonance imaging (MRI) compatible. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070556204
Device count
1
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
00817617020518Curaplex8600-011968600-011962016-12-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956565364CARDINAL HEALTHCardinal Health 200, LLCOGH2026-10-29
10198956377196CARDINAL HEALTHCardinal Health 200, LLCOGH2026-03-31
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50198956330625CARDINAL HEALTHCardinal Health 200, LLCOGH2026-02-09
05707480163205Ambu® SureSight® Mobile Mini KitAmbu A/SOGH2025-12-19
05707480163267Ambu® SureSight® Mobile KitAmbu A/SOGH2025-12-19
05707480163212Ambu® SureSight® Mobile Mini KitAmbu A/SOGH2025-12-19
05707480163274Ambu® SureSight® Mobile KitAmbu A/SOGH2025-12-19
00860009615533Intubation Guide KitNar Medical Depot, LLCOGK2025-07-15
00860009615540Intubation Guide KitNar Medical Depot, LLCOGK2025-07-15
00860009615557Intubation Guide KitNar Medical Depot, LLCOGK2025-07-15
10197106816394CARDINAL HEALTHCardinal Health 200, LLCOGH2024-10-31
50197106816392CARDINAL HEALTHCardinal Health 200, LLCOGH2024-10-31
10197106728970CARDINAL HEALTHCardinal Health 200, LLCOGH2024-08-21
50197106728978CARDINAL HEALTHCardinal Health 200, LLCOGH2024-08-21
10197106314395CARDINAL HEALTHCardinal Health 200, LLCOGH2023-11-14
50197106314393CARDINAL HEALTHCardinal Health 200, LLCOGH2023-11-14
10197106409015CARDINAL HEALTHCardinal Health 200, LLCOGH2023-08-31
50197106409013CARDINAL HEALTHCardinal Health 200, LLCOGH2023-08-31
00191072194480ACSAMERICAN CONTRACT SYSTEMS, INC.OGH2023-05-01
00612649181264Video laryngoscope aBlade kitKing Systems CorporationOGH2022-12-08
00810094574765CuraplexBOUND TREE MEDICAL, LLCLNZ2022-12-08
00612649178073King Vision Video Laryngoscope KitKing Systems CorporationOGH2022-12-08
00612649182100Video laryngoscope aBlade kitKing Systems CorporationOGH2022-12-08
10195594579692CARDINAL HEALTHCardinal Health 200, LLCOGH2022-05-06
50195594579690CARDINAL HEALTHCardinal Health 200, LLCOGH2022-05-06
00810071633133CuraplexBOUND TREE MEDICAL, LLCLNZ2022-03-31
00810071633140CuraplexBOUND TREE MEDICAL, LLCLNZ2022-03-31
00810071633157CuraplexBOUND TREE MEDICAL, LLCLNZ2022-03-31
00810071633164CuraplexBOUND TREE MEDICAL, LLCLNZ2022-03-31