Echotip Insight ECHO-PPG

GUDID 00827002465602

Echotip Insight Portosystemic Pressure Gradient Measurement System

COOK IRELAND LTD

Endoscopic portal pressure measurement system

• Primary Device ID: 00827002465602
• NIH Device Record Key: 20d69606-a004-4c63-a651-ce8856aa1902
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Echotip Insight
• Version Model Number: G46560
• Catalog Number: ECHO-PPG
• Company DUNS: 988559035
• Company Name: COOK IRELAND LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place. Avoid extended exposure to light.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002465602 [Primary]

FDA Product Code

• QIJ: Endoscopic transhepatic venous access needle

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-23
• Device Publish Date: 2019-12-12

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