FDA.report

Laerdal Disposable PEEP Valve Assembly

Primary DI
07045432082500
Brand
Laerdal Disposable PEEP Valve Assembly
Company
Laerdal Medical AS
Model
845140
Catalog number
845140
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
2017-11-22
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

Related Records

Contact Domains

Product Codes

CodeName
BYEAttachment, Breathing, Positive End Expiratory Pressure

Product Code Classifications

CodeDeviceSpecialtyClass
BYEAttachment, Breathing, Positive End Expiratory PressureAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07045432084108PackageGS110In Commercial Distribution
07045432082500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07045432084108070454320841087045432084108
07045432082500070454320825007045432082500

GMDN Terms

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

TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Contacts

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

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