Urethral Intermittent Catheter Tray

GUDID 00616784492834

DYNAREX CORPORATION

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• 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

Devices Manufactured by DYNAREX CORPORATION

• 08401173287854 - DynaCare Tampons,Super,Plastic Applicator: 2024-04-17 Unscented, Free of Dyes & Perfumes
• 00860008059512 - IV Start Kit: 2024-04-10
• 00840117333215 - Instant Cold Pack, 4" x 5": 2024-04-08 For use whenever instant cold therapy is required
• 00616784046617 - Homecare Half Length Bed Rail Cross Bar Mount: 2024-04-05
• 00616784706313 - IV Extension Sets Needle-Free Luer Lock Connector for Injection Non-Toxic: 2024-04-02 15" , Sterile
• 00840117333000 - XeroBurn Sterile Burn Dressing Blanket: 2024-04-02 30" x 35"
• 00840117333024 - XeroBurn Sterile Burn Dressing Blanket 60"x 70": 2024-04-02 60"x 70"
• 00840117333048 - XeroBurn Sterile Burn Dressing Blanket 70" x 95": 2024-04-02 70" x 95"