McKesson CPR Mask, Barrier Dev. w/O2 73509

Basic Information

• Brand Name: McKesson CPR Mask, Barrier Dev. w/O2 73509
• Primary DI: 07045432101683
• Version / Model: 830046
• Catalog Number: 830046
• Company Name: Laerdal Medical AS
• Labeler DUNS: 730624095
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-04
• Public Version: 3
• Public Version Date: 2023-02-14
• Public Version Status: Update
• Public Device Record Key: 1a424315-5a70-4342-84c5-a24cf85f8122
• Distribution End Date: 2023-02-01

Device Description

The McKesson CPR Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult.

Device Characteristics

• Single Use: No
• 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
CBP	Valve, Non-Rebreathing	Anesthesiology	868.5870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36066	Cardiopulmonary resuscitation mask, reusable	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). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07045432101690	GS1	Carton	100	Not in Commercial Distribution	2023-02-01
Primary	07045432101683	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -40 – 52 Degrees Celsius