Laerdal Disposable PEEP Valve Assembly

Basic Information

• Brand Name: Laerdal Disposable PEEP Valve Assembly
• Primary DI: 07045432082500
• Version / Model: 845140
• Catalog Number: 845140
• Company Name: Laerdal Medical AS
• Labeler DUNS: 730624095
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-22
• Public Version: 3
• Public Version Date: 2023-11-01
• Public Version Status: Update
• Public Device Record Key: 839937f6-82b2-48a0-a4b3-88d9d719c9c8
• Distribution End Date: 2023-10-31

Device Description

The Laerdal Disposable PEEP Valve Assembly is a single patient use accessory for use with all models of Laerdal brand resuscitators to enable clinicians to apply and adjust the level of PEEP therapy being administered to a patient. The PEEP Valve connector is the standard 30 mm ID size

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
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	868.5965	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46823	PEEP valve, single-use	A non-sterile device used in a respiratory or anaesthesia breathing circuit or system to maintain a selected level of positive end expiratory pressure (PEEP) in a patient's airway during ventilation. The device is typically constructed of plastic and metal materials, and has a valve(s) actuated with a spring(s) to provide the airway resistance, and an adjustable knob or dial (usually graduated) to adjust the resistance level typically between 5 to 20 cmH2O. It is used with ventilators, stand-alone breathing systems for oxygen delivery, pulmonary resuscitators, or anaesthetic breathing systems often having an expiratory valve function. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07045432082500	GS1
Package	07045432084108	GS1		10	Not in Commercial Distribution	2023-10-31

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 0 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -40 – 60 Degrees Celsius