The BAG PEEP Valve 5-20 cmH2O

Basic Information

• Brand Name: The BAG PEEP Valve 5-20 cmH2O
• Primary DI: 07045432116113
• Version / Model: 8470211
• Catalog Number: 8470211
• Company Name: Laerdal Medical AS
• Labeler DUNS: 730624095
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-14
• Public Version: 1
• Public Version Date: 2026-01-22
• Public Version Status: New
• Public Device Record Key: 56bc234b-8906-4c5f-8523-70486f2e9948

Device Description

The BAG PEEP Valve is a non-sterile single patient use accessory for maintaining positive end-expiratory pressure (PEEP) with Laerdal The BAG resuscitator. It may be used for single-patient multiple use when kept free from contamination.

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: Yes
• MRI Safety: MR Conditional
• 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
Package	07045432116090	GS1	Carton	12	In Commercial Distribution
Primary	07045432116113	GS1

Premarket Submissions

Submission Number	Supplement Number
K251631	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius