PhysioFlow

Basic Information

• Brand Name: PhysioFlow
• Primary DI: 03760125071046
• Version / Model: Lab1
• Company Name: MANATEC
• Labeler DUNS: 261064453
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-07
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 0d048640-7826-4961-8a74-cef774a93ce4

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: No
• 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
DSB	Plethysmograph, Impedance	Cardiovascular	870.2770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12103	Impedance cardiograph	A device that records the variations in thoracic electrical impedance caused by the activity of the heart muscle, usually detected at the body surface. A current is passed through the body and the product of this current and the body impedance is the electrical potential difference between two sensing electrodes. The graphic representation of the variation of the impedance with time is recorded in a diagram (impedance cardiogram). It is used to study the action of the heart muscle, for diagnosis of specific cardiac abnormalities, and to reveal trends or changes in heart function, especially cardiac output. Some types may include additional measurements (e.g., pulse oximetry, blood pressure).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760125071046	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K060387	000