FDA.reportPublic FDA data

PEEP 1unit for UDI for 845040

Primary DI
07045432068696
Brand
PEEP 1unit for UDI for 845040
Company
Laerdal Medical AS
Model
20-09502
Catalog number
20-09502
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 clinicia
Published
2015-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYEAttachment, Breathing, Positive End Expiratory Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYEAttachment, Breathing, Positive End Expiratory PressureAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07045430078680PackageGS110In Commercial Distribution
07045432068696PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07045430078680070454300786807045430078680
07045432068696070454320686967045432068696

GMDN Terms#

Term, Definition table
TermDefinition
PEEP valve, single-useA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800)4311055customerservice@laerdal.com

Regulatory Flags#

DUNS number
730624095
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07045432120462Laerdal Silicone Masks851500-12026-01-29
07045432120479Laerdal Silicone Masks851600-12026-01-29
07045432120486Laerdal Silicone Masks851700-1 2026-01-29
07045432120493Laerdal Silicone Masks860220-12026-01-29
07045432120509Laerdal Silicone Masks870220-12026-01-29
07045432115987The BAG Mask size 18470111 8470111 2026-01-14
07045432115994The BAG Mask size 2 847012184701212026-01-14
07045432116007The BAG Mask size 3 8470128470122026-01-14
07045432116014The BAG Mask size 484701412026-01-14
07045432116021The BAG Mask size 5847015184701512026-01-14
07045432116083The BAG PEEP Valve 2-10 cmH2O847021184702112026-01-14
07045432116090The BAG PEEP Valve 5-20 cmH2O8470211 8470211 2026-01-14
07045432116144The BAG Manometer8470401 8470401 2026-01-14
07045432118179Pocket Mask, PB (DE FR ES IT EN)82002133820021332025-08-27
07045432118285Pocket Mask, SP Blue (DE FR ES IT EN)82002133820021332025-08-27
07045432119244Pocket Mask, HC Yellow (DE FR ES IT EN)82002133820021332025-08-27
07045432118186Pocket Mask, PB (EN)82000133820001332025-08-25
07045432118230Pocket Mask, SP Blue (EN)82002133820021332025-08-25
07045432119282Pocket Mask, HC White Private Label8299328299322025-08-25
07045432119305Pocket Mask, SP Black Private Label8299228299222025-08-25

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Primary DI, Brand, Company table
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07045432116083The BAG PEEP Valve 2-10 cmH2OLaerdal Medical ASBYE2026-01-14
07045432116090The BAG PEEP Valve 5-20 cmH2OLaerdal Medical ASBYE2026-01-14
10889483228708WaterPAP™SUNMED, LLCBYE2025-12-15
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