Hayden Medical

Basic Information

• Brand Name: Hayden Medical
• Primary DI: 00840319717967
• Version / Model: 029-604
• Catalog Number: 029-604
• Company Name: Hayden Medical, Inc.
• Labeler DUNS: 618214410
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-03
• Public Version: 1
• Public Version Date: 2022-08-11
• Public Version Status: New
• Public Device Record Key: 992c3a43-50cb-438b-ae38-803f998f9f68

Device Description

MACINTOSH laryngoscope blade fig 4, integrated fiber optic, green system, reusable, working length 5-3/8" (136 mm)

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: No
• 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: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
Primary	00840319717967	GS1

Customer Contacts

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