BOD POD® GS-X Body Composition System

GUDID 00866203000236

The BOD 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 generally healthy individuals. The BOD POD is also indicated for estimating Resting Metabolic Rate (RMR) and Total Energy Expenditure (TEE) in generally healthy individuals aged 18 years or older.

COSMED USA, INC.

Densitometry body composition analyser

• Primary Device ID: 00866203000236
• NIH Device Record Key: 1a466eaa-a314-44de-a81c-2091e0de73c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BOD POD® GS-X Body Composition System
• Version Model Number: 2020
• Company DUNS: 020221102
• Company Name: COSMED USA, 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: 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
• Phone: 19256766002
• Email: serviceusa@cosmed.com
• Phone: 19256766002
• Email: serviceusa@cosmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866203000236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060848

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-28
• Device Publish Date: 2020-10-20

Devices Manufactured by COSMED USA, INC.

• 00866203000236 - BOD POD® GS-X Body Composition System: 2020-10-28The BOD 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 generally healthy individuals. The BOD POD is also indicated for estimating Resting Metabolic Rate (RMR) and Total Energy Expenditure (TEE) in generally healthy individuals aged 18 years or older.
• 00866203000236 - BOD POD® GS-X Body Composition System: 2020-10-28 The BOD POD® is indicated for measuring the body mass and estimating the body composition (i.e. percent and absolute amounts of
• 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: 2018-07-06 The PEA POD® Infant Body Composition System (“PEA POD”) is indicated for measuring the body mass and estimating the body co