PEA POD® Infant Body Composition System

Primary DI
00866203000229
Brand
PEA POD® Infant Body Composition System
Company
COSMED USA, INC.
Model
PEA POD Infant Body Composition System
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.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OACPlethysmograph, Air Displacement For Body Composition Analysis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OACPlethysmograph, Air Displacement For Body Composition AnalysisCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032610000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032610000MODIFIED SONAMET BODY COMPOSITION ANALYZERLife Measurement, Inc.2004-03-01OAC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866203000229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866203000229008662030002298662030002290866203000229

GMDN Terms#

Term, Definition table
TermDefinition
Bioelectrical body composition analyserAn electronic device designed to estimate body composition (i.e., percent body fat, lean, bone, and/or hydration) with regards to bioelectrical impedance analysis (BIA) and often personal characteristics (e.g., age, gender, height, weight). It may be in the form of a unit with electrodes applied to the surface of the patient’s body, or a scale(s) placed on the floor and upon which the patient stands to measure total body weight. Both types perform BIA by passing a low electrical current through the body; personal characteristics may be manually entered. Data are analysed to provide measurements that may include body mass index (BMI), fat/muscle/bone mass, and total body water percent.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-5.8 Degrees Fahrenheit167 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
19256766002serviceusa@cosmed.com

Regulatory Flags#

DUNS number
020221102
Device count
1
DM exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00866203000243PEA POD Infant Body Composition SystemPP20252026-04-16
00866203000236BOD POD® GS-X Body Composition System20202020-10-20
00866203000205BOD POD® Body Composition System2007A2016-09-21
00866203000212BOD POD® Body Composition System2007B2016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00866203000243PEA POD Infant Body Composition SystemCOSMED USA, INC.OAC2026-04-16
00866203000236BOD POD® GS-X Body Composition SystemCOSMED USA, INC.OAC2020-10-20
00866203000205BOD POD® Body Composition SystemCOSMED USA, INC.OAC2016-09-21
00866203000212BOD POD® Body Composition SystemCOSMED USA, INC.OAC2016-09-21