Newborn Mask - Size 0 Qty 10 - Snap Design (US)

Basic Information

• Brand Name: Newborn Mask - Size 0 Qty 10 - Snap Design (US)
• Primary DI: 07045432092448
• Version / Model: LGH-84615601
• Catalog Number: LGH-84615601
• Company Name: Laerdal Medical AS
• Labeler DUNS: 730624095
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-28
• Public Version: 1
• Public Version Date: 2020-11-05
• Public Version Status: New
• Public Device Record Key: f5701e3d-bc1d-48ed-9ce1-7fb1792f8424

Device Description

Newborn Masks are intended for face mask ventilation of newborns and infants.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BYG	Mask, Oxygen	Anesthesiology	868.5580	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17170	Resuscitator face mask, reusable	A flexible, form-shaped device that is placed over a patient's nose and mouth to direct ambient air, or medical oxygen (O2) and air, from a resuscitator to the upper airway and lungs. It is typically made of non-conductive sterilizable materials (e.g., silicone) that will create a gastight seal against the face. It will typically include a 15 mm and/or 22 mm connector and is available in a range of sizes (baby to adult). It will be directly attached to the resuscitator and held in place on the patient's face by the operator. This device is intended for use with a breathing resuscitator but may be used for the delivery of anaesthesia gases. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07045432092448	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 40 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -40 – 60 Degrees Celsius