Newborn Mask - Size 0 Qty 10 - Snap Design 84615601

GUDID 07045432087321

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

Laerdal Medical AS

Resuscitator face mask, reusable

• Primary Device ID: 07045432087321
• NIH Device Record Key: f3744da1-b682-4e5e-976a-8fba12fd1a44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Newborn Mask - Size 0 Qty 10 - Snap Design
• Version Model Number: 84615601
• Catalog Number: 84615601
• Company DUNS: 730624095
• Company Name: Laerdal Medical AS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com
• Phone: (800)4311055
• Email: customerservice@laerdal.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07045432087321 [Primary]

FDA Product Code

• BYG: Mask, Oxygen

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

[07045432087321]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-05
• Device Publish Date: 2020-10-28

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• 07045432112269 - Newborn Mask - Size 0 Qty 1 - Snap Design: 2022-12-08 Newborn Masks are intended for face mask ventilation of newborns and infants. Ref 10-pack cases Models: 84615601, LGH-84615601
• 07045432112399 - Newborn Mask - Size 1 Qty 1 - Snap Design (US): 2022-12-08 Newborn Masks are intended for face mask ventilation of newborns and infants. Ref 10-pack cases Models: 84615701, LGH-84615701
• 07045432101690 - McKesson CPR Mask, Barrier Dev. w/O2 73509: 2021-12-14 The McKesson CPR Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult.