AccessGUDID - DEVICE: Elite CPR Face Shield (00816703023112)

GUDID

Device Identifier (DI) Information

Brand Name: Elite CPR Face Shield
Version or Model: ELITE-21105
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Not Applicable
Company Name: MEDSOURCE INTERNATIONAL LLC

Primary DI Number: 00816703023112
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041674552 *Terms of Use

Device Description: CPR Face Shield / Elite First Aid Part Number: 605

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?
63222	Cardiopulmonary resuscitation mouthpiece/cover	A non-sterile device that consists of a mouthpiece with an integrated face/body covering sheet intended to be placed over a patient during cardiopulmonary resuscitation (CPR) to prevent cross-contamination between patient and CPR administrator; it may also include directions/positional markers printed on the cover intended to assist the administrator during CPR. The mouthpiece is designed to be used as a barrier during resuscitation (i.e., “mouth-to-mouthpiece”) as an alternative to conventional “mouth-to-mouth”. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGB	Mask, Oxygen, Non-Rebreathing

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: 219eb139-bac7-4d73-9321-98e9a93214eb
Public Version Date: November 29, 2022
Public Version Number: 2
DI Record Publish Date: April 20, 2021