Echotip Insight

Basic Information

• Brand Name: Echotip Insight
• Primary DI: 00827002465602
• Version / Model: G46560
• Catalog Number: ECHO-PPG
• Company Name: COOK IRELAND LTD
• Labeler DUNS: 988559035
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-12
• Public Version: 2
• Public Version Date: 2019-12-23
• Public Version Status: Update
• Public Device Record Key: 20d69606-a004-4c63-a651-ce8856aa1902

Device Description

Echotip Insight Portosystemic Pressure Gradient Measurement System

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QIJ	Endoscopic transhepatic venous access needle	Gastroenterology, Urology	876.1050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64175	Endoscopic portal pressure measurement system	An assembly of devices intended to measure hepatic portal pressure gradient by direct measurements of pressure within the hepatic vein and portal vein using a needle inserted via the stomach or duodenum under ultrasound guidance during endoscopy. It consists of a fine needle, a mechanical manometer with connection tubing, and a syringe. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002465602	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in dark, dry, cool place. Avoid extended exposure to light.