American Medicals

Basic Information

• Brand Name: American Medicals
• Primary DI: B35604350600
• Version / Model: 1
• Company Name: American Medicals
• Labeler DUNS: 109909627
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-20
• Public Version: 1
• Public Version Date: 2022-09-28
• Public Version Status: New
• Public Device Record Key: 433ccd11-5a51-498d-a7bc-a7cc5855270e

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Microwave Radiation

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCW	Laryngoscope, Rigid	Anesthesiology	868.5540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60381	Laryngoscope light-emitting cell	A non-sterile, portable, battery-powered device intended to provide the light source for a laryngoscope (i.e., rigid intubation type) when fitted into the laryngoscope handle. It typically consists of a removable cylindrical cell that produces light which is emitted from the laryngoscope handle via a fibreoptic laryngoscope blade for airway illumination. The device may be kinetically or electrically recharged. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B35604350600	HIBCC