Closed Circuit Foley Catheter Tray - Sterile - 18 FR

GUDID 00616784500737

DYNAREX CORPORATION

Urethral catheterization support kit, urinary drainage

• Primary Device ID: 00616784500737
• NIH Device Record Key: beb4a48d-d250-4e8a-9a8a-49f58858bffd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Closed Circuit Foley Catheter Tray - Sterile - 18 FR
• Version Model Number: 5007
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 10
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784500720 [Unit of Use]
GS1	00616784500737 [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: 2
• Public Version Date: 2019-04-09
• Device Publish Date: 2018-08-18

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