McGRATH MAC

Basic Information

• Brand Name: McGRATH MAC
• Primary DI: 10884521823396
• Version / Model: 301-000-000
• Company Name: AIRCRAFT MEDICAL LTD.
• Labeler DUNS: 222254083
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-30
• Public Version: 4
• Public Version Date: 2024-01-25
• Public Version Status: Update
• Public Device Record Key: 31acf84e-d02f-43d4-ba91-d14fc06d31ac

Device Description

Video Laryngoscope

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
15076	Rigid intubation laryngoscope, reusable	A hand-held 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 can be magnetic resonance imaging (MRI) compatible. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521823393	GS1	PACK_OR_INNER_PACK	20	In Commercial Distribution
Primary	10884521823396	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 50 – 104 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 14 – 104 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: .62 – 1.06 KiloPascal
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: .62 – 1.06 KiloPascal