AccessGUDID - DEVICE: Keyring w/LFS x 25 (US) Yellow (07045431500197)

GUDID

Device Identifier (DI) Information

Brand Name: Keyring w/LFS x 25 (US) Yellow
Version or Model: 46990801
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 46990801
Company Name: Laerdal Medical AS

Primary DI Number: 07045431500197
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 730624095 *Terms of Use

Device Description: The Laerdal Face Shield (LFS) is a single use medical device intended as a CPR barrier between a rescuer and a patient and to aid rescuers trained in resuscitation, in mouth-to-mouth resuscitation of non-breathing patients. Its hydrophobic filter gives the user and the victim effective protection. It is available in a convenient sealed key ring.

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):	Yes
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?
61326	Cardiopulmonary resuscitation mask, single-use	A flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS) or as part of first aid kits. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTM	Ventilator, Emergency, Manual (Resuscitator)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K880450	000

Device Exempt from Premarket Submission: No 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
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8dbc058c-9eec-4747-867c-d174f4dca71c
Public Version Date: August 09, 2022
Public Version Number: 4
DI Record Publish Date: October 20, 2015