Adult Silicone Mask 4-5+ w/o Multi-Func Mask Cover 870221

GUDID 07045432033946

Laerdal Silicone Masks are intended to be used for ventilation of patients. The multi-function Mask Cover is intended to be used to add additional support, when needed, to Laerdal Silisone Masks (sizes 3-4, 4-5+) and to allow for strapping of Laerdal Silicone Masks to the patient.

Laerdal Medical AS

Resuscitator face mask, reusable

• Primary Device ID: 07045432033946
• NIH Device Record Key: 7615a367-df51-41d4-98d3-ef21214c6692
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adult Silicone Mask 4-5+ w/o Multi-Func Mask Cover
• Version Model Number: 870221
• Catalog Number: 870221
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07045432033946 [Primary]

FDA Product Code

• BYG: Mask, Oxygen

Sterilization

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

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

Devices Manufactured by Laerdal Medical AS

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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.
• 07045430041257 - Laerdal Thomas Tube Holder Adult: 2021-10-28 The Thomas Tube Holder secures advanced airway devices, such as Endotracheal Tubes and Supraglottic Airway devices, after insert
• 07045430041264 - Laerdal Thomas Tube Holder Pedi: 2021-10-28 The Thomas Tube Holder secures advanced airway devices, such as Endotracheal Tubes and Supraglottic Airway devices, after insert
• 07045430041271 - Laerdal Thomas Tube Holder Adult (Green): 2021-10-28 The Thomas Tube Holder secures advanced airway devices, such as Endotracheal Tubes and Supraglottic Airway devices, after insert
• 07045432072310 - Laerdal Thomas Select Tube Holder, Adult: 2021-10-28 The Thomas Tube Holder secures advanced airway devices, such as Endotracheal Tubes and Supraglottic Airway devices, after insert