PEEP 1unit for UDI for 845040 - The Laerdal Disposable PEEP Valve Assembly is a - Laerdal Medical AS

Duns Number:730624095

Device Description: The Laerdal Disposable PEEP Valve Assembly is a single patient use accessory for use with 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

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More Product Details

Catalog Number

20-09502

Brand Name

PEEP 1unit for UDI for 845040

Version/Model Number

20-09502

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 01, 2019

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

BYE

Product Code Name

Attachment, Breathing, Positive End Expiratory Pressure

Device Record Status

Public Device Record Key

e543ad51-17cb-45d7-81ac-a4bdfcc4687f

Public Version Date

August 19, 2020

Public Version Number

3

DI Record Publish Date

October 19, 2015

Additional Identifiers

Package DI Number

07045430078680

Quantity per Package

10

Contains DI Package

07045432068696

Package Discontinue Date

October 01, 2019

Package Status

Not in Commercial Distribution

Package Type

Carton

"LAERDAL MEDICAL AS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 80