AccessGUDID - DEVICE: Key Surgical Bite Blocks (00849771037200)

GUDID

Device Identifier (DI) Information

Brand Name: Key Surgical Bite Blocks
Version or Model: EN-315
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EN315
Company Name: KEY SURGICAL, INC.

Primary DI Number: 00849771037200
Issuing Agency: GS1
Commercial Distribution End Date: November 10, 2023
Device Count: 25
Labeler D-U-N-S® Number*: 604056226 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNK	Endoscopic Bite Block

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d7f90282-c024-4287-9fd0-56ba827088a2
Public Version Date: November 13, 2023
Public Version Number: 4
DI Record Publish Date: December 09, 2020