NeoNatalie Complete Light (US) 104-10004

GUDID 07045432001938

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: 07045432001938
• NIH Device Record Key: bbc2cc9b-bce6-4729-9408-d2355c76a324
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoNatalie Complete Light (US)
• Version Model Number: 104-10004
• Catalog Number: 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: (800)431-1055
• Email: customerservice@laerdal.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 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	07045432001938 [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

[07045432001938]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-09

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