Omada

Basic Information

• Brand Name: Omada
• Primary DI: B726BT005O0
• Version / Model: BT005
• Company Name: BODYTRACE, INC
• Labeler DUNS: 116841525
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-06
• Public Version: 1
• Public Version Date: 2020-07-14
• Public Version Status: New
• Public Device Record Key: e16e035d-1b99-49e4-9c74-a353573191bb

Device Description

Weight scale.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
FRI	Scale, Stand-On, Patient	General Hospital	880.2700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38211	Stand-on floor scale, electronic	An electrically-powered device designed to be placed on/integrated into the floor and upon which a patient is intended to stand to measure and display total body weight. It is not designed to weigh a wheelchair-bound patient or bed/stretcher.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B726BT005O1	HIBCC	Individual box	1	In Commercial Distribution
Primary	B726BT005O0	HIBCC
Package	B726BT005O2	HIBCC	5-piece carton	5	In Commercial Distribution

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 55 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 80 – 105 KiloPascal
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 80 – 105 KiloPascal