Paed. PM w/o wipe and gloves CPR Barrier Dev.

Basic Information

• Brand Name: Paed. PM w/o wipe and gloves CPR Barrier Dev.
• Primary DI: 07045430078673
• Version / Model: 820053
• Catalog Number: 820053
• Company Name: Laerdal Medical AS
• Labeler DUNS: 730624095
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-19
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 1e9d9d0b-0705-4901-b988-1499f763145d

Device Description

The Laerdal Paediatric Pocket Mask is a device designed for mouth-to-mask ventilation of a non-breathing child or infant.

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
CBP	Valve, Non-Rebreathing	Anesthesiology	868.5870	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	07045430078673	GS1
Package	07045432068504	GS1	Carton	10	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K023805	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -40 – 50 Degrees Celsius