ManoScan

Basic Information

• Brand Name: ManoScan
• Primary DI: 05704736001304
• Version / Model: 9012P1392
• Catalog Number: 9012P1392
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2017-05-17
• Public Version: 6
• Public Version Date: 2022-09-05
• Public Version Status: Update
• Public Device Record Key: 28f2380e-a08b-4466-9179-4ee135207cb8
• Distribution End Date: 2017-08-17

Device Description

4 ch Anorectal Cat. Sil. w/Bal,

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KLA	MONITOR, ESOPHAGEAL MOTILITY, AND TUBE	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	05704736001304	GS1
Unit of Use	10884521742703	GS1

Customer Contacts

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