n.a.

Basic Information

• Brand Name: n.a.
• Primary DI: 04250105601985
• Version / Model: 40-26-040-1
• Company Name: VBM Medizintechnik GmbH
• Labeler DUNS: 324869601
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-31
• Public Version: 2
• Public Version Date: 2024-01-09
• Public Version Status: Update
• Public Device Record Key: b989296a-34e1-41c3-9c48-8b8dfba628ae
• Distribution End Date: 2024-01-08

Device Description

Guedel Airway with elastic necktape

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
42424	Oropharyngeal airway, single-use	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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14250105601982	GS1		30	Not in Commercial Distribution	2024-01-08
Primary	04250105601985	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			#4 ; 10.0 cm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: keep dry, keep away from sunlight and heat