PEA POD® Infant Body Composition System

GUDID 00866203000229

The PEA POD® Infant Body Composition System (“PEA POD”) is indicated for measuring the body mass and estimating the body composition (i.e., percent and absolute amounts of fat and lean body mass) of subjects between 1 and 8 kilograms. It is not intended for use with subjects requiring life support.

COSMED USA, INC.

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• Primary Device ID: 00866203000229
• NIH Device Record Key: aa523b0b-36b1-4470-9a99-4ce149cb81da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEA POD® Infant Body Composition System
• Version Model Number: PEA POD Infant Body Composition System
• Company DUNS: 020221102
• Company Name: COSMED USA, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 19256766002
• Email: serviceusa@cosmed.com
• Phone: 19256766002
• Email: serviceusa@cosmed.com
• Phone: 19256766002
• Email: serviceusa@cosmed.com
• Phone: 19256766002
• Email: serviceusa@cosmed.com
• Phone: 19256766002
• Email: serviceusa@cosmed.com
• Phone: 19256766002
• Email: serviceusa@cosmed.com
• Phone: 19256766002
• Email: serviceusa@cosmed.com
• Phone: 19256766002
• Email: serviceusa@cosmed.com
• Phone: 19256766002
• Email: serviceusa@cosmed.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -5.8 Degrees Fahrenheit and 167 Degrees Fahrenheit
• Storage Environment Temperature: Between -5.8 Degrees Fahrenheit and 167 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5.8 Degrees Fahrenheit and 167 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5.8 Degrees Fahrenheit and 167 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5.8 Degrees Fahrenheit and 167 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5.8 Degrees Fahrenheit and 167 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5.8 Degrees Fahrenheit and 167 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5.8 Degrees Fahrenheit and 167 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5.8 Degrees Fahrenheit and 167 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5.8 Degrees Fahrenheit and 167 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866203000229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032610

FDA Product Code

• OAC: Plethysmograph, Air Displacement For Body Composition Analysis

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: 2018-07-06
• Device Publish Date: 2016-09-23

Devices Manufactured by COSMED USA, INC.

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• 00866203000205 - BOD POD® Body Composition System: 2018-07-06 The BOD POD® is indicated for measuring the body mass and estimating the body composition (i.e. percent and absolute amounts of
• 00866203000212 - BOD POD® Body Composition System: 2018-07-06 The BOD POD® is indicated for measuring the body mass and estimating the body composition (i.e. percent and absolute amounts of
• 00866203000229 - PEA POD® Infant Body Composition System: 2018-07-06The PEA POD® Infant Body Composition System (“PEA POD”) is indicated for measuring the body mass and estimating the body composition (i.e., percent and absolute amounts of fat and lean body mass) of subjects between 1 and 8 kilograms. It is not intended for use with subjects requiring life support.
• 00866203000229 - PEA POD® Infant Body Composition System: 2018-07-06 The PEA POD® Infant Body Composition System (“PEA POD”) is indicated for measuring the body mass and estimating the body co