Lullaby

GUDID 00840682117401

DATEX-OHMEDA INC

Overhead infant phototherapy unit

• Primary Device ID: 00840682117401
• NIH Device Record Key: a6282a2b-37cb-44f5-9281-275b3086c3b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lullaby
• Version Model Number: LED Phototherapy System
• Company DUNS: 080887689
• Company Name: DATEX-OHMEDA INC
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: +1(800)345 2700
• Email: xx@xx.xx
• Phone: +1(800)345 2700
• Email: xx@xx.xx
• Phone: +1(800)345 2700
• Email: xx@xx.xx
• Phone: +1(800)345 2700
• Email: xx@xx.xx
• Phone: +1(800)345 2700
• Email: xx@xx.xx
• Phone: +1(800)345 2700
• Email: xx@xx.xx
• Phone: +1(800)345 2700
• Email: xx@xx.xx
• Phone: +1(800)345 2700
• Email: xx@xx.xx
• Phone: +1(800)345 2700
• Email: xx@xx.xx
• Phone: +1(800)345 2700
• Email: xx@xx.xx
• Phone: +1(800)345 2700
• Email: xx@xx.xx
• Phone: +1(800)345 2700
• Email: xx@xx.xx
• Phone: +1(800)345 2700
• Email: xx@xx.xx
• Phone: +1(800)345 2700
• Email: xx@xx.xx
• Phone: +1(800)345 2700
• Email: xx@xx.xx
• Phone: +1(800)345 2700
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682117401 [Primary]

FDA Product Code

• LBI: UNIT, NEONATAL PHOTOTHERAPY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-04-19
• Device Publish Date: 2016-06-24

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