PEA POD® Infant Body Composition System

Basic Information

• Brand Name: PEA POD® Infant Body Composition System
• Primary DI: 00866203000229
• Version / Model: PEA POD Infant Body Composition System
• Company Name: COSMED USA, INC.
• Labeler DUNS: 020221102
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2020-10-21
• Public Version Status: Update
• Public Device Record Key: aa523b0b-36b1-4470-9a99-4ce149cb81da

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OAC	Plethysmograph, Air Displacement For Body Composition Analysis	Cardiovascular	870.2770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64281	Densitometry body composition analyser	An electrically-powered stationary device intended to use whole-body densitometry to determine body composition (percent and absolute body fat, and fat-free mass) based on manually-entered subject demographic data (e.g., age, gender, height), body weight, and body volume. The system includes controls and display, a scale for body weight measurement, and a closable cabin-like chamber with pre-calibrated air pressure sensors for determining body volume using air displacement plethysmography (by the application of pressure-volume relationships).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00866203000229	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K032610	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -5.8 – 167 Degrees Fahrenheit