Keyring w/LFS x 25 (US) Blue

Basic Information

• Brand Name: Keyring w/LFS x 25 (US) Blue
• Primary DI: 07045431500210
• Version / Model: 46991101
• Catalog Number: 46991101
• Company Name: Laerdal Medical AS
• Labeler DUNS: 730624095
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2015-10-20
• Public Version: 4
• Public Version Date: 2022-08-09
• Public Version Status: Update
• Public Device Record Key: b4658abe-7307-4fb2-80e5-2fb0f54d73d2

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

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• 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
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	868.5915	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07045431500210	GS1
Unit of Use	07045432068641	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K880450	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius