AccessGUDID - DEVICE: Laerdal Paediatric PM w/Gloves in Red/Black (07045430075559)

GUDID

Device Identifier (DI) Information

Brand Name: Laerdal Paediatric PM w/Gloves in Red/Black
Version or Model: 820052
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 820052
Company Name: Laerdal Medical AS

Primary DI Number: 07045430075559
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 730624095 *Terms of Use

Device Description: The Laerdal Paediatric Pocket Mask is a device designed for mouth-to-mask ventilation of a non-breathing child or infant.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Cardiopulmonary resuscitation mask, single-use	A flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS) or as part of first aid kits. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Cardiopulmonary resuscitation mask, single-use

A flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS) or as part of first aid kits. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
CBP	Valve, Non-Rebreathing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K023805	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 50 Degrees Celsius

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c98fb5f0-4384-4daf-8e33-a2757b26207c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 19, 2015