MEDLINE

Basic Information

• Brand Name: MEDLINE
• Primary DI: 20197344137234
• Version / Model: DYNDPACK8
• Catalog Number: DYNDPACK8
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2025-04-07
• Public Version: 2
• Public Version Date: 2026-03-19
• Public Version Status: Update
• Public Device Record Key: 79619ebc-166b-45dc-98ed-12c60a4582dc

Device Description

GUEDEL AIRWAY PACK, EIGHT SIZES

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: No
• Has Manufacturing Date: No
• 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
CAE	AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY	Anesthesiology	868.5110	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42423	Oropharyngeal airway, reusable	A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10197344137237	GS1
Primary	20197344137234	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	4	Decimeter
Length	5	Centimeter
Length	6	Centimeter
Length	7	Centimeter
Length	8	Centimeter
Length	9	Centimeter
Length	10	Centimeter
Length	11	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry