FDA.report

Oral Airways, Disposable

Primary DI
00616784476513
Brand
Oral Airways, Disposable
Company
Dynarex Corporation
Model
4765
Device description
Oral Airways, Disposable, X-Large, 110 mm, Orange
Published
2020-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
CAEAirway, Oropharyngeal, Anesthesiology

Product Code Classifications

CodeDeviceSpecialtyClass
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784476520PrimaryGS10
00616784476513Unit of UseGS10

GMDN Terms

TermDefinition
Laryngoscope blade, single-useThe segment of a laryngoscope (i.e., rigid intubation type) intended to be inserted into the oral cavity 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 is connected to the laryngoscope handle and illumination of the airway is provided by a small built-in light bulb or a fibreoptic light. This device may be curved or straight and of various designs and lengths; it may be hinged/interchanged with the handle. Some types are magnetic resonance imaging (MRI) compatible. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810180843331Durma+ DynaRule Disposable Paper Rulers30062026-03-24
00810180845106Cotton Tipped Wood Applicators, Sterile43042022-04-22
00810180845113Cotton Tipped Wood Applicators, Sterile43052022-04-22
00810180840712CurPro Dermal Curettes,2 mm 41552024-12-16
00840117347892Medi-Cut Safety Scalpel41652022-04-17
00810180844901Disposable Prep Razors42512020-11-02
00810180844918Medicine Cups 1oz 42522024-10-28
00810180844925LabChoice Specimen Container, Screw-On, Leak-Resistant Lid, Tamper-Ever Seal 42542021-06-21
00810180844703Bandage Shears 7.5" Orange4183-BX2020-11-08
00810180844710Bandage Shears 7.5" Purple4184-BX2020-11-08
00810180844840Emesis Basin42242022-05-02
00810180844857Sitz Bath42282021-09-01
00810180844864Urinal- Male42292021-09-01
00810180844871Bed Pans42302021-04-22
00810180844888Bed Pans42312021-04-22
00810180844895Nuns Cap Specimen Collector42322021-04-22
00840117331822DynaSafety Heavy Duty Woven Fabric Knuckle Bandages, 1 1/2" x 3"3765BULK2024-03-08
00840117331853DynaSafety Heavy Duty Woven Fabric Bandages, Large Patch, 2" x 3"3766BULK2024-03-08
00840117331907DynaSafety Heavy Duty Woven Fabric Bandages, Sterile, 7/8" x 3"3767BULK2024-03-08
00840117350045Pill Crusher Pouch42102021-09-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
16946430425208CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425215CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425222CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425239CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425246CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425253CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425260CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425277CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425284CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425291CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425307CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425314CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425321CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425338CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425345CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425352CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425369CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425376CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425383CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425390CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425406CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425413CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425420CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425437CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425444CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
45060112316102LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-12-10
35060112316112LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-11-17
00840117340428Resp-O2 Disposable Guedel Airway, 120 mm, Adult XX-Large, Lavender Dynarex CorporationCAE2025-09-29
25060112310618LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-09-11
15060112311038LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-09-11