Urethral Intermittent Catheter Tray

GUDID 00616784492834

DYNAREX CORPORATION

Urethral catheterization support kit, urinary drainage

• Primary Device ID: 00616784492834
• NIH Device Record Key: bfa53f2c-9c1b-465b-b33f-27f4a5bcf20f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Urethral Intermittent Catheter Tray
• Version Model Number: 4928
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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	00616784492827 [Unit of Use]
GS1	00616784492834 [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: 2016-11-22

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• 00616784704210 - IV Administration Sets, 10 mL, Non-Toxic: 2025-08-11 Sterile-EO
• 00616784704418 - IV Administration Set, 20 mL, Non-Toxic: 2025-08-11 Sterile-EO