McGRATH

Basic Information

• Brand Name: McGRATH
• Primary DI: 35060272980086
• Version / Model: X3-003-000
• Company Name: AIRCRAFT MEDICAL LTD.
• Labeler DUNS: 222254083
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-22
• Public Version: 15
• Public Version Date: 2022-06-01
• Public Version Status: Update
• Public Device Record Key: 0f07d381-aae4-478a-a3ca-8ea8d3bf3f5e

Device Description

McGRATH (TM) X3 Disposable Laryngoscope Blade

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCW	LARYNGOSCOPE, RIGID	Anesthesiology	868.5540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46828	Laryngoscope blade, single-use	The 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	15060272980082	GS1	PACK_OR_INNER_PACK	10	In Commercial Distribution
Primary	35060272980086	GS1
Package	25060272980089	GS1	CASE	30	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Fragile, Keep dry, This side up, Stacking limitations
• Type: Handling Environment Temperature
• Temperature Range: 14 – 158 Degrees Fahrenheit