Solar GI HRAM H2O, 24p, Trolley system

Basic Information

• Brand Name: Solar GI HRAM H2O, 24p, Trolley system
• Primary DI: 08717775955009
• Version / Model: G3-14
• Company Name: Medical Measurement Systems B.V.
• Labeler DUNS: 416277333
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: d62d10fb-3718-4fac-989a-25c7fb9638e9

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: Yes
• 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: No
• 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
FFX	SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)	Gastroenterology, Urology	876.1725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15036	Gastroduodenal motility analysis system	An assembly of devices designed to evaluate peristaltic motility in the stomach and/or small intestines (usually the duodenum) by measuring pressure on an intragastric catheter/probe at several points. It typically includes a monitor display, computer, software, pressure catheter/probe, and a pH electrode to measure the acidity of the stomach contents. The system is intended to evaluate several diseases of the stomach and small intestines including the prediction of gastric and/or duodenal ulcers.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08717775955009	GS1

Premarket Submissions

Submission Number	Supplement Number
K121014	000