Key Surgical Bite Blocks

Basic Information

• Brand Name: Key Surgical Bite Blocks
• Primary DI: 00849771037200
• Version / Model: EN-315
• Catalog Number: EN315
• Company Name: KEY SURGICAL, INC.
• Labeler DUNS: 604056226
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2020-12-09
• Public Version: 4
• Public Version Date: 2023-11-13
• Public Version Status: Update
• Public Device Record Key: d7f90282-c024-4287-9fd0-56ba827088a2
• Distribution End Date: 2023-11-10

Device Description

Bite Block, O2-CO2 monitoring and oxygen delivery, with strap

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
MNK	Endoscopic Bite Block	Gastroenterology, Urology	876.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47162	Endoscopic bite block, oxygenating	A dual-purpose device inserted into a patient's mouth to maintain oral patency during an endoscopic procedure primarily to protect the endoscope, introduced via the mouth, from the patient's natural tendency to bite down on the instrument, and that simultaneously supports an oxygen (O2) line to provide the patient with an uninterrupted flow of O2 during and after endoscopy. The device also protects the tongue and teeth of the patient during endoscopy and may include a gas sample line that enables monitoring of the expired carbon dioxide (CO2) during the procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00849771043843	GS1
Primary	00849771037200	GS1

Customer Contacts

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