HDM97

Basic Information

• Brand Name: HDM97
• Primary DI: EIBPHDM97BH501
• Version / Model: HDM97BH50
• Company Name: IBP Medical GmbH
• Labeler DUNS: 312507464
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-01
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 160082d0-8d86-486a-a766-58d4679814cc

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: 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
FIZ	Meter, Conductivity, Non-Remote	Gastroenterology, Urology	876.5820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35001	Multi-parameter device tester	A battery-powered electronic device designed to measure two or more parameters (e.g., temperature, conductivity, pressure, pH, flow) to calibrate or test a medical device (e.g., haemodialysis equipment, anaesthesia machine, suction system, ophthalmic laser). It typically consists of a hand-held electronic box with appropriate connections and a digital display; dedicated measuring devices (e.g., probe, sensor, electrode, buffer solution) are typically included. It is not dedicated to a specific clinical discipline and is intended to be used by a professional in a professional setting (e.g., clinical engineering).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EIBPHDM97BH501	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K020908	000