n.a.

Basic Information

• Brand Name: n.a.
• Primary DI: 04250105605495
• Version / Model: 40-70-060
• Company Name: VBM Medizintechnik GmbH
• Labeler DUNS: 324869601
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-02
• Public Version: 1
• Public Version Date: 2020-09-10
• Public Version Status: New
• Public Device Record Key: d7b4140e-c922-4af7-991c-6e26a5e8da83

Device Description

Biteblock

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: 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: 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
Package	14250105605492	GS1		10	In Commercial Distribution
Primary	04250105605495	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			#6 ; suitable for Laryngeal Tubes: LT / LTS II #3, #4, #5 / Laryngeal Masks #3, #4, #5

Storage Conditions

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