NeoNatalie Complete Light LGH-104-10004

GUDID 07045432091168

The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and infants up to 5 kg body mass who require respiratory s

Laerdal Medical AS

Pulmonary resuscitator, manual, reusable

• Primary Device ID: 07045432091168
• NIH Device Record Key: b5387433-cff7-49ad-a412-cc582a14cd39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoNatalie Complete Light
• Version Model Number: LGH-104-10004
• Catalog Number: LGH-104-10004
• Company DUNS: 730624095
• Company Name: Laerdal Medical AS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (877) 523-7325
• Email: cutomerservice@laerdal.com

Device Dimensions

• Weight: 5 Kilogram

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07045432091168 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132172

FDA Product Code

• BTM: Ventilator, Emergency, Manual (Resuscitator)

Sterilization

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

[07045432091168]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-04
• Device Publish Date: 2019-01-02

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