AccessGUDID - DEVICE: BOD POD® Body Composition System (00866203000212)

GUDID

Device Identifier (DI) Information

Brand Name: BOD POD® Body Composition System
Version or Model: 2007B
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: COSMED USA, INC.

Primary DI Number: 00866203000212
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 020221102 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAC	Plethysmograph, Air Displacement For Body Composition Analysis

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060848	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 40 and 100 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4293ffbe-302c-4318-9ab6-90c820180f53
Public Version Date: October 21, 2020
Public Version Number: 4
DI Record Publish Date: September 21, 2016