FDA.reportPublic FDA data

PEAK MEDICAL

Primary DI
G453335200112L0
Brand
PEAK MEDICAL
Company
Peak Medical Distribution Inc.
Model
3352001-12L
Device description
COHEN CANNULA, LARGE, STAINLESS STEEL, NON REMOVABLE ACORN
Published
2026-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GEACannula, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G453335200112L0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube cannula, reusableA hollow, cylindrical, curved device designed as an internal, independent component of a metal tracheostomy tube. It is made of metal [e.g., high-grade stainless steel and/or silver (Ag) or silver plated brass] or plastic and has precise dimensions allowing it to fit exactly into the outer tube and function as the inner cannula for tracheostomy tubes that have this kind of function. It is removed once or more times daily to facilitate the removal of phlegm, slime, and contamination build-up, thereby preventing blockage and infection of the stoma and eliminates the traumatic removal of the tracheostomy tube. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
078393632
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G4531121L0PEAK MEDICAL1121L2026-10-28
G4531121M0PEAK MEDICAL1121M2026-10-28
G4531121S0PEAK MEDICAL1121S2026-10-28
G453332786800PEAK MEDICAL3327-86802023-05-01
G453521954312M0PEAK MEDICAL52105-43-12M2026-10-20
G4533310960PEAK MEDICAL33-10962026-10-19
G453521053112M0PEAK MEDICAL52105-31-12M2025-10-01
G4533352105310PEAK MEDICAL335210-5312025-08-13
G4533310930PEAK MEDICAL33-10932026-08-27
G453FCE2004SI0PEAK MEDICALFCE-2004-SI2026-08-25
G453FCE2005SI0PEAK MEDICALFCE-2005-SI2026-08-25
G453FCE2006SI0PEAK MEDICALFCE-2006-SI2026-08-25
G453FCE2007SI0PEAK MEDICALFCE-2007-SI2026-08-25
G453333630140PEAK MEDICAL3336-30142026-08-14
G4533315010BC0PEAK MEDICAL33-15010-BC2026-08-07
G4533315012BC0PEAK MEDICAL33-15012-BC2026-08-07
G453PM1840W0PEAK MEDICALPM-1840W2026-07-29
G453152901750PEAK MEDICAL15-29-1752026-07-14
G4533306290PEAK MEDICAL33-06292026-06-24
G4533312250PEAK MEDICAL33-12252026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G4531121L0PEAK MEDICALPeak Medical Distribution Inc.GEA2026-10-28
G4531121M0PEAK MEDICALPeak Medical Distribution Inc.GEA2026-10-28
G4531121S0PEAK MEDICALPeak Medical Distribution Inc.GEA2026-10-28
00810130456901Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456918Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456925Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456932Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456949Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456956Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456963Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456970Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456987Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456994Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457007Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457014Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457021Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457038Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457045Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457052Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457069Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457076Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457083Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457106Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457113Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457120Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457137Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457144Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457168Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457175Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457182Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23