AccessGUDID - DEVICE: Grafco (M3683786B21)

GUDID

Device Identifier (DI) Information

Brand Name: Grafco
Version or Model: 3786B#2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3786B#2
Company Name: GF HEALTH PRODUCTS, INC.

Primary DI Number: M3683786B21
Issuing Agency: HIBCC
Commercial Distribution End Date: October 13, 2020
Device Count: 100
Labeler D-U-N-S® Number*: 132016168 *Terms of Use

Device Description: BERMAN ORAL AIRWAY (60MM) SML CHLD

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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PHS	Oral Airway Assist

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: 3590d0d3-e7e7-4ddc-b390-ff7759631ab8
Public Version Date: January 21, 2022
Public Version Number: 2
DI Record Publish Date: October 13, 2020