Closed Circuit Foley Catheter Tray

GUDID 00616784500638

DYNAREX CORPORATION

Urethral catheterization support kit, urinary drainage

• Primary Device ID: 00616784500638
• NIH Device Record Key: 3b95e6f9-c114-4523-a8ee-a721e60c4a8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Closed Circuit Foley Catheter Tray
• Version Model Number: 5006
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 10
• 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: 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
GS1	00616784500621 [Unit of Use]
GS1	00616784500638 [Primary]

FDA Product Code

• OHR: Catheter Care Tray

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: 2019-04-09
• Device Publish Date: 2016-09-24

On-Brand Devices [Closed Circuit Foley Catheter Tray]

• 00616784500638: 5006
• 00616784500539: 5005
• 00616784500430: 5004
• 00616748500737: 5007