LSR Paedi. Std. Term w/Mask in Carton (IE - The Laerdal Silicone Resuscitator is a - Laerdal Medical AS

Duns Number:730624095

Device Description: The Laerdal Silicone Resuscitator is a self-inflating manual resuscitator that is intended The Laerdal Silicone Resuscitator is a self-inflating manual resuscitator that is intended for patients requiring total or intermittent ventilatory support. The Laerdal Silicone Resuscitator provides positive pressure ventilation and allows spontaneous breathing either with a 22 mm ID (inner diameter) face - mask port, through an artificial airway or with a facemask that has a 15 mm OD (outer diameter) connection. The Preterm model is intended for patients below 2,5 kg (5,5 lb), the Paediatric model is intended for patients from 2,5 (5,5 lb) to 25 kg (55 lb), and the Adult model is intended for pati - ents over 25 kg (55 lb).

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More Product Details

Catalog Number

86005633

Brand Name

LSR Paedi. Std. Term w/Mask in Carton (IE

Version/Model Number

86005633

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

BTM

Product Code Name

Ventilator, Emergency, Manual (Resuscitator)

Device Record Status

Public Device Record Key

28e30819-0bdc-4107-9a93-02e304ae4bfc

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 16, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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