ZepHr

Basic Information

• Brand Name: ZepHr
• Primary DI: 00816734022160
• Version / Model: Z07-2000-B-A
• Catalog Number: Z07-2000-B-A
• Company Name: DIVERSATEK HEALTHCARE, INC.
• Labeler DUNS: 030650113
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 8
• Public Version Date: 2023-06-14
• Public Version Status: Update
• Public Device Record Key: dc08598d-4004-4cdb-a15b-4fb443c2d153

Device Description

ZepHr® pH Recorder

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: 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
35053	Manometric gastrointestinal motility analysis system	An assembly of devices which includes a main computerized unit designed to evaluate peristaltic motility in the gastrointestinal tract by measuring pressure using an intraluminal sensor catheter/probe at several points; it may also measure pH, respiration, and swallowing with appropriate sensors. In addition to the central computer with software it may includethe appropriate perfusion and/or nonperfusion catheters. It is intended to evaluate patients with dysphagia, gastro-oesophageal reflux disease (GERD), noncardiac chest pain, and/or assess connective tissue and neuromuscular disease.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816734022160	GS1
Secondary	B019Z072000BA0	HIBCC

Customer Contacts

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