COVIDIEN

GUDID B15064967234

30ML PREFILLED SYRINGE

NURSE ASSIST, INC.

Device-irrigation sterile water

• Primary Device ID: B15064967234
• NIH Device Record Key: c3f92b71-6e05-4536-9479-43c249f19326
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COVIDIEN
• Version Model Number: 6496723
• Company DUNS: 869434464
• Company Name: NURSE ASSIST, INC.
• Device Count: 200
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B15064967230 [Unit of Use]
HIBCC	B15064967234 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030813

FDA Product Code

• EZL: Catheter, Retention Type, Balloon

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [COVIDIEN]

• B15088815731254: 8881573125
• B15088815731252: 8881573125
• B15088815731234: 8881573123
• B15088815731232: 8881573123
• B15088815731214: 8881573121
• B15088815731212: 8881573121
• B15064967234: 30ML PREFILLED SYRINGE
• B15064967224: 10ML PREFILLED SYRINGE